<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02985957</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-650</org_study_id>
    <secondary_id>2016-001928-54</secondary_id>
    <nct_id>NCT02985957</nct_id>
  </id_info>
  <brief_title>A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)</brief_title>
  <acronym>CheckMate 650</acronym>
  <official_title>A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</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>
      The purpose of this study is to evaluate the effectiveness, safety and tolerability of&#xD;
      nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate&#xD;
      cancer (mCRPC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 26, 2017</start_date>
  <completion_date type="Anticipated">October 6, 2026</completion_date>
  <primary_completion_date type="Actual">April 5, 2022</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) Cohorts B and C Per BICR</measure>
    <time_frame>From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) Cohort D</measure>
    <time_frame>From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR</measure>
    <time_frame>From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Progression-Free Survival (rPFS) for Cohort D</measure>
    <time_frame>From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)</time_frame>
    <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per BICR assessment&#xD;
Bone disease progression by (Prostate Cancer Working Group) PCWG2&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C</measure>
    <time_frame>From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D</measure>
    <time_frame>From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)</time_frame>
    <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) Cohorts B and C</measure>
    <time_frame>From first dose to the date of death due to any cause (assessed up to approximately 61 months)</time_frame>
    <description>Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) Cohort D</measure>
    <time_frame>From randomization to the date of death due to any cause (assessed up to approximately 61 months)</time_frame>
    <description>Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C</measure>
    <time_frame>From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D</measure>
    <time_frame>From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
    <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs) in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)</time_frame>
    <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).</time_frame>
    <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Who Died in Cohorts A, B and C</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).</time_frame>
    <description>Death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Who Died in Cohort D</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).</time_frame>
    <description>Death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>The number of participants with an change in laboratory values from baseline Grade in Cohort D.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C</measure>
    <time_frame>At baseline and Week 4 (Cycle 2)</time_frame>
    <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D</measure>
    <time_frame>At baseline and 4 weeks after first dose.</time_frame>
    <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D</measure>
    <time_frame>At baseline and 4 weeks after first dose.</time_frame>
    <description>The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C</measure>
    <time_frame>At baseline and at Week 4 of Cycle 2.</time_frame>
    <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D</measure>
    <time_frame>At baseline and 4 weeks after first dose.</time_frame>
    <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">351</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A (Arm A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B (Arm B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C (Arm C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D (Arm D1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D (Arm D2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D (Arm D3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D (Arm D4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Cohort A (Arm A)</arm_group_label>
    <arm_group_label>Cohort B (Arm B)</arm_group_label>
    <arm_group_label>Cohort C (Arm C)</arm_group_label>
    <arm_group_label>Cohort D (Arm D1)</arm_group_label>
    <arm_group_label>Cohort D (Arm D2)</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Cohort A (Arm A)</arm_group_label>
    <arm_group_label>Cohort B (Arm B)</arm_group_label>
    <arm_group_label>Cohort C (Arm C)</arm_group_label>
    <arm_group_label>Cohort D (Arm D1)</arm_group_label>
    <arm_group_label>Cohort D (Arm D2)</arm_group_label>
    <arm_group_label>Cohort D (Arm D3)</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabazitaxel</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Cohort D (Arm D4)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Cohort D (Arm D4)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Current evidence of metastatic disease documented by either bone lesions on&#xD;
             radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic&#xD;
             resonance imaging (CT/MRI).&#xD;
&#xD;
          -  Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone&#xD;
             (GnRH) analogue or a surgical/medical castration with testosterone level of&#xD;
             ≤1.73nmol/L (50ng/dL)&#xD;
&#xD;
        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:&#xD;
&#xD;
          -  Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma&#xD;
             of the prostate and evidence of Stage IV disease (as defined by American Joint&#xD;
             Committee of Cancer criteria (AJCC criteria) prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of visceral metastases in the liver&#xD;
&#xD;
          -  Active brain metastases or leptomeningeal metastases&#xD;
&#xD;
          -  Active, known, or suspected autoimmune disease or infection&#xD;
&#xD;
          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or&#xD;
             any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint&#xD;
             pathways&#xD;
&#xD;
        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:&#xD;
&#xD;
          -  Prior radiation therapy within 14 days prior to first dose of nivolumab combined with&#xD;
             ipilimumab&#xD;
&#xD;
          -  Have received systemic anti-cancer therapy after the last dose of study treatment&#xD;
             (ipilimumab or cabazitaxel)&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 0074</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0046</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0076</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0075</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0078</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0065</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0077</name>
      <address>
        <city>Tigard</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0047</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0067</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0079</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0059</name>
      <address>
        <city>Wahroonga</city>
        <state>New South Wales</state>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0043</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4012</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Elizabeth Vale</city>
        <state>South Australia</state>
        <zip>5112</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0044</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0063</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Kobenhavn O</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0060</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0004</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0003</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0041</name>
      <address>
        <city>Braunschweig</city>
        <zip>38114</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0032</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Goettingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Herne</city>
        <zip>44625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0017</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0034</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0037</name>
      <address>
        <city>Nuernberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>Nuertingen</city>
        <zip>72622</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0036</name>
      <address>
        <city>Rostock</city>
        <zip>18107</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0033</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0035</name>
      <address>
        <city>Wesel</city>
        <zip>46483</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0071</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0053</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0072</name>
      <address>
        <city>Parma</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0051</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0055</name>
      <address>
        <city>Kraków</city>
        <state>Małopolskie</state>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0066</name>
      <address>
        <city>Koszalin</city>
        <zip>75-581</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0054</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Badajoz</city>
        <zip>06006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0021</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Santiago Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>March 30, 2023</results_first_submitted>
  <results_first_submitted_qc>April 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2023</results_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02985957/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Cohort A: Asymptomatic or minimally symptomatic, not previously received second generation hormone therapies or cytotoxic chemotherapy.&#xD;
Cohort B: Asymptomatic or minimally symptomatic, progressed after second generation hormone therapies and had not been treated with cytotoxic chemotherapy.&#xD;
Cohort C: Progressed after prior taxane-based cytotoxic chemotherapy. Cohort D: Progressed after prior docetaxel-containing therapy.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="P2">
          <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="P3">
          <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="P4">
          <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
          <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
        </group>
        <group group_id="P5">
          <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
          <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
        </group>
        <group group_id="P6">
          <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
          <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
        <group group_id="P7">
          <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
          <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="73"/>
                <participants group_id="P5" count="74"/>
                <participants group_id="P6" count="38"/>
                <participants group_id="P7" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="73"/>
                <participants group_id="P5" count="73"/>
                <participants group_id="P6" count="38"/>
                <participants group_id="P7" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</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 group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="73"/>
                <participants group_id="P5" count="73"/>
                <participants group_id="P6" count="38"/>
                <participants group_id="P7" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Eligible Participants Who Progressed and Received Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="25"/>
              </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="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="19"/>
                <participants group_id="P7" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="73"/>
                <participants group_id="P6" count="19"/>
                <participants group_id="P7" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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 group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not reported</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum clinical benefit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study drug toxicity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="19"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="39"/>
                <participants group_id="P5" count="29"/>
                <participants group_id="P6" count="11"/>
                <participants group_id="P7" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</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="4"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-Compliance</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 group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Continuing in Treatment Period</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="B2">
          <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="B3">
          <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="B4">
          <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
          <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
        </group>
        <group group_id="B5">
          <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
          <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
        </group>
        <group group_id="B6">
          <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
          <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
        <group group_id="B7">
          <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
          <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
        <group group_id="B8">
          <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="2"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="45"/>
            <count group_id="B4" value="73"/>
            <count group_id="B5" value="74"/>
            <count group_id="B6" value="38"/>
            <count group_id="B7" value="74"/>
            <count group_id="B8" value="351"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement 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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="23"/>
                    <measurement group_id="B8" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="22"/>
                    <measurement group_id="B7" value="51"/>
                    <measurement group_id="B8" value="227"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="74"/>
                    <measurement group_id="B6" value="38"/>
                    <measurement group_id="B7" value="74"/>
                    <measurement group_id="B8" value="351"/>
                  </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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="56"/>
                    <measurement group_id="B6" value="28"/>
                    <measurement group_id="B7" value="51"/>
                    <measurement group_id="B8" value="270"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="22"/>
                    <measurement group_id="B8" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="70"/>
                    <measurement group_id="B5" value="72"/>
                    <measurement group_id="B6" value="32"/>
                    <measurement group_id="B7" value="67"/>
                    <measurement group_id="B8" value="313"/>
                  </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="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR) Cohorts B and C Per BICR</title>
        <description>Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
        <time_frame>From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All treated Cohort B and C participants with measurable disease at baseline; pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Cohorts B and C Per BICR</title>
          <description>Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
          <population>All treated Cohort B and C participants with measurable disease at baseline; pre-specified only to be collected for Cohorts B and C.</population>
          <units>Percent 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="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="3.5" upper_limit="29.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="7.7" upper_limit="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR) Cohort D</title>
        <description>In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
        <time_frame>From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Cohort D</title>
          <description>In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).&#xD;
Confidence-interval based on Clopper Pearson method.</description>
          <population>All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Percent 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="45"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="2.5" upper_limit="21.2"/>
                    <measurement group_id="O2" value="15.2" lower_limit="6.3" upper_limit="28.9"/>
                    <measurement group_id="O3" value="4.3" lower_limit="0.1" upper_limit="21.9"/>
                    <measurement group_id="O4" value="11.1" lower_limit="3.7" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR</title>
        <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All treated Cohort B and C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR</title>
          <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All treated Cohort B and C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.59" lower_limit="3.65" upper_limit="10.22"/>
                    <measurement group_id="O2" value="5.36" lower_limit="2.92" upper_limit="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Progression-Free Survival (rPFS) for Cohort D</title>
        <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per BICR assessment&#xD;
Bone disease progression by (Prostate Cancer Working Group) PCWG2&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)</time_frame>
        <population>All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression-Free Survival (rPFS) for Cohort D</title>
          <description>Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.&#xD;
The following progressive diseases were collected, documented and assessed as below:&#xD;
Radiographic progression per BICR assessment&#xD;
Bone disease progression by (Prostate Cancer Working Group) PCWG2&#xD;
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" lower_limit="2.17" upper_limit="7.62"/>
                    <measurement group_id="O2" value="4.17" lower_limit="3.32" upper_limit="5.59"/>
                    <measurement group_id="O3" value="3.48" lower_limit="2.14" upper_limit="5.78"/>
                    <measurement group_id="O4" value="7.92" lower_limit="5.55" upper_limit="9.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C</title>
        <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All treated Cohort B, C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C</title>
          <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All treated Cohort B, C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" lower_limit="2.79" upper_limit="5.49"/>
                    <measurement group_id="O2" value="3.71" lower_limit="2.10" upper_limit="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D</title>
        <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)</time_frame>
        <population>All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D</title>
          <description>Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.&#xD;
Radiographic progression per Investigator assessment:&#xD;
Bone disease progression by Prostate Cancer Working Group (PCWG2)&#xD;
Non-bone soft tissue disease progression by RECIST v1.1&#xD;
Clinical progression per investigator assessment:&#xD;
Need for palliative radiation therapy involving more than one site, OR&#xD;
Surgery of kyphoplasty to any neoplastic lesion, OR&#xD;
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" lower_limit="2.10" upper_limit="3.22"/>
                    <measurement group_id="O2" value="3.68" lower_limit="2.23" upper_limit="4.63"/>
                    <measurement group_id="O3" value="2.66" lower_limit="2.04" upper_limit="3.71"/>
                    <measurement group_id="O4" value="5.85" lower_limit="3.84" upper_limit="7.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) Cohorts B and C</title>
        <description>Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From first dose to the date of death due to any cause (assessed up to approximately 61 months)</time_frame>
        <population>All treated participants in Cohorts B and C; pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Cohorts B and C</title>
          <description>Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All treated participants in Cohorts B and C; pre-specified only to be collected for Cohorts B and C.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.75" lower_limit="13.90" upper_limit="23.56"/>
                    <measurement group_id="O2" value="15.21" lower_limit="8.44" upper_limit="17.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) Cohort D</title>
        <description>Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
        <time_frame>From randomization to the date of death due to any cause (assessed up to approximately 61 months)</time_frame>
        <population>All randomized participants in Cohort D.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Cohort D</title>
          <description>Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.&#xD;
Based on Kaplan-Meier estimates.</description>
          <population>All randomized participants in Cohort D.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" lower_limit="12.78" upper_limit="17.68"/>
                    <measurement group_id="O2" value="13.47" lower_limit="10.38" upper_limit="16.66"/>
                    <measurement group_id="O3" value="18.46" lower_limit="10.74" upper_limit="NA">Upper limit of the survival curve did not reach 50% thus, there is no estimate for the upper confidence limit on the median.</measurement>
                    <measurement group_id="O4" value="14.78" lower_limit="11.40" upper_limit="16.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C</title>
        <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
        <time_frame>From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All treated participants with PSA values at baseline and at least one postbaseline assessment in Cohorts B and C. Pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C</title>
          <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
          <population>All treated participants with PSA values at baseline and at least one postbaseline assessment in Cohorts B and C. Pre-specified only to be collected for Cohorts B and C.</population>
          <units>Percent 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="34"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" lower_limit="6.8" upper_limit="34.5"/>
                    <measurement group_id="O2" value="10.0" lower_limit="2.8" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D</title>
        <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
        <time_frame>From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)</time_frame>
        <population>All randomized participants with PSA values at baseline and at least one post-baseline assessment in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D</title>
          <description>The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.&#xD;
Confidence-interval based on Clopper Pearson method.</description>
          <population>All randomized participants with PSA values at baseline and at least one post-baseline assessment in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Percent 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="65"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="5.8" upper_limit="22.1"/>
                    <measurement group_id="O2" value="16.2" lower_limit="8.7" upper_limit="26.6"/>
                    <measurement group_id="O3" value="5.3" lower_limit="0.6" upper_limit="17.7"/>
                    <measurement group_id="O4" value="23.0" lower_limit="14.0" upper_limit="34.2"/>
                    <measurement group_id="O5" value="25.0" lower_limit="5.5" upper_limit="57.2"/>
                    <measurement group_id="O6" value="16.0" lower_limit="4.5" upper_limit="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>All treated participants in Cohorts A, B and C</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants in Cohorts A, B and C</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs) in Cohort D</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs) in Cohort D</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="69"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C</title>
        <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>All treated participants in Cohorts A, B and C</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C</title>
          <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>All treated participants in Cohorts A, B and C</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D</title>
        <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D</title>
          <description>A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="32"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>All treated participants in Cohorts A, B and C</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants in Cohorts A, B and C</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C</title>
        <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)</time_frame>
        <population>All treated participants in Cohorts A, B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C</title>
          <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
          <population>All treated participants in Cohorts A, B and C.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea/Colitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism/Thyroiditis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D</title>
        <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).</time_frame>
        <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D</title>
          <description>Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.</description>
          <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea/Colitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism/Thyroiditis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Who Died in Cohorts A, B and C</title>
        <description>Death due to any cause.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).</time_frame>
        <population>All treated participants in Cohorts A, B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Who Died in Cohorts A, B and C</title>
          <description>Death due to any cause.</description>
          <population>All treated participants in Cohorts A, B and C.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Who Died in Cohort D</title>
        <description>Death due to any cause.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).</time_frame>
        <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O5">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
            <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O6">
            <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
            <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Who Died in Cohort D</title>
          <description>Death due to any cause.</description>
          <population>All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C</title>
        <description>The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>All treated participants in Cohorts A, B and C with baseline laboratory measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C</title>
          <description>The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.</description>
          <population>All treated participants in Cohorts A, B and C with baseline laboratory measurements.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypernatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyponatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D</title>
        <description>The number of participants with an change in laboratory values from baseline Grade in Cohort D.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>All treated participants in Cohort D with baseline laboratory measurements. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D</title>
          <description>The number of participants with an change in laboratory values from baseline Grade in Cohort D.</description>
          <population>All treated participants in Cohort D with baseline laboratory measurements. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="56"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypernatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyponatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C</title>
        <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>All Treated Participants in Cohorts A, B and C with at least one on-treatment liver function measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C</title>
          <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
          <population>All Treated Participants in Cohorts A, B and C with at least one on-treatment liver function measurement.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT OR AST &gt; 3XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 5XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 10XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST &gt; 20XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TOTAL BILIRUBIN &gt; 2XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D</title>
        <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>All Treated Participants in Cohort D with at least one on-treatment liver function measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D</title>
          <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.&#xD;
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
          <population>All Treated Participants in Cohort D with at least one on-treatment liver function measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT OR AST &gt; 3XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 5XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 10XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST &gt; 20XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TOTAL BILIRUBIN &gt; 2XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP&gt;1.5XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CONCURR ALT/ AST ELEV&gt;3XULN WITH TOT BILI&gt;1.5XULN WITHIN 1 DAY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CONCURR ALT/ AST ELEV&gt;3XULN WITH TOT BILI&gt;1.5XULN WITHIN 30 DAYS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CONCURR ALT/ AST ELEV&gt;3XULN WITH TOT BILI&gt;2XULN WITHIN 1 DAY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CONCURR ALT/ AST ELEV&gt;3XULN WITH TOT BILI&gt;2XULN WITHIN 30 DAYS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C</title>
        <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)</time_frame>
        <population>Treated participants in Cohorts A, B and C with at least one on-treatment TSH measurement. Treated subjects in Cohort B with adequate follow-up of at least 24 weeks are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C</title>
          <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
          <population>Treated participants in Cohorts A, B and C with at least one on-treatment TSH measurement. Treated subjects in Cohort B with adequate follow-up of at least 24 weeks are included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TSH &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH TSH &lt;= ULN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ALL OTHER FT3/FT4 TEST VALUES &gt;= LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH TSH &gt;= LLN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ALL OTHER FT3/FT4 TEST VALUES &lt;= ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D</title>
        <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)</time_frame>
        <population>Treated participants in Cohort D with at least one on-treatment TSH measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D</title>
          <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.&#xD;
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
          <population>Treated participants in Cohort D with at least one on-treatment TSH measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TSH &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH TSH &lt;= ULN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ALL OTHER FT3/FT4 TEST VALUES &gt;= LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH TSH &gt;= LLN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ALL OTHER FT3/FT4 TEST VALUES &lt;= ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C</title>
        <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
        <time_frame>At baseline and Week 4 (Cycle 2)</time_frame>
        <population>All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C</title>
          <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
          <population>All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worst pain in the last 24 hours Week 4 (Cycle 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-4" upper_limit="5"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-5" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Least pain in the last 24 hours Week 4 (Cycle 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-3" upper_limit="1"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain in the last 24 hours Week 4 (Cycle 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-3" upper_limit="2"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-4" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current pain Week 4 (Cycle 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-3" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="-5" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D</title>
        <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
        <time_frame>At baseline and 4 weeks after first dose.</time_frame>
        <population>All randomized Cohort D participants with baseline and week 4 scores</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D</title>
          <description>Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a &quot;worse&quot; outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
          <population>All randomized Cohort D participants with baseline and week 4 scores</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worst pain in the last 24 hours Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-7" upper_limit="8"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-5" upper_limit="7"/>
                    <measurement group_id="O3" value="-0.1" lower_limit="-8" upper_limit="6"/>
                    <measurement group_id="O4" value="-0.5" lower_limit="-7" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Least pain in the last 24 hours Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-7" upper_limit="8"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-4" upper_limit="4"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-4" upper_limit="5"/>
                    <measurement group_id="O4" value="-0.3" lower_limit="-5" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain in the last 24 hours Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-6" upper_limit="6"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-5" upper_limit="6"/>
                    <measurement group_id="O3" value="-0.3" lower_limit="-5" upper_limit="5"/>
                    <measurement group_id="O4" value="-0.4" lower_limit="-5" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current pain Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-6" upper_limit="6"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-4" upper_limit="4"/>
                    <measurement group_id="O3" value="-0.4" lower_limit="-6" upper_limit="6"/>
                    <measurement group_id="O4" value="-0.3" lower_limit="-6" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D</title>
        <description>The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.</description>
        <time_frame>At baseline and 4 weeks after first dose.</time_frame>
        <population>All randomized Cohort D participants with baseline and week 4 scores; pre-specified for data to be collected only from Cohort D participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D</title>
          <description>The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.</description>
          <population>All randomized Cohort D participants with baseline and week 4 scores; pre-specified for data to be collected only from Cohort D participants.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" lower_limit="-60.2" upper_limit="116.4"/>
                    <measurement group_id="O2" value="-4.74" lower_limit="-81.0" upper_limit="72.7"/>
                    <measurement group_id="O3" value="-3.64" lower_limit="-91.5" upper_limit="65"/>
                    <measurement group_id="O4" value="-0.28" lower_limit="-71.7" upper_limit="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C</title>
        <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
        <time_frame>At baseline and at Week 4 of Cycle 2.</time_frame>
        <population>All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
            <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C</title>
          <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
          <population>All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0083" lower_limit="-0.311" upper_limit="0.275"/>
                    <measurement group_id="O2" value="-0.0074" lower_limit="-0.327" upper_limit="0.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D</title>
        <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
        <time_frame>At baseline and 4 weeks after first dose.</time_frame>
        <population>All randomized Cohort D participants with baseline and week 4 scores</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W</title>
            <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
            <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
            <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
            <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D</title>
          <description>The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.</description>
          <population>All randomized Cohort D participants with baseline and week 4 scores</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0032" lower_limit="-0.736" upper_limit="0.791"/>
                    <measurement group_id="O2" value="-0.0328" lower_limit="-0.574" upper_limit="0.532"/>
                    <measurement group_id="O3" value="0.0113" lower_limit="-0.532" upper_limit="0.463"/>
                    <measurement group_id="O4" value="0.0219" lower_limit="-0.514" upper_limit="0.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants will be assessed for All-Cause Mortality from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 63 months; ongoing until study completion occurs). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (an average of 4.83 months assessed up to approximately 29.5 months).</time_frame>
      <desc>The number at Risk for All-Cause Mortality represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication for all Cohorts. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="E2">
          <title>Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="E3">
          <title>Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg</title>
          <description>Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.</description>
        </group>
        <group group_id="E4">
          <title>Arm D1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg</title>
          <description>Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
        </group>
        <group group_id="E5">
          <title>Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W</title>
          <description>Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.</description>
        </group>
        <group group_id="E6">
          <title>Cohort D Arm 3: Ipilimumab 3 mg/kg</title>
          <description>Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
        <group group_id="E7">
          <title>Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg</title>
          <description>Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.</description>
        </group>
        <group group_id="E8">
          <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3</title>
          <description>Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
        </group>
        <group group_id="E9">
          <title>Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4</title>
          <description>Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="44" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="48" subjects_at_risk="74"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="50" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="49" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="18" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Agranulocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Overflow diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pancreatolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection reactivation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nerve root injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Postoperative wound complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Troponin T increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </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" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Joint neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="18" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cerebellar stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bladder neck obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bladder obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Ureteric stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Autoimmune lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diaphragmalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Iliac vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="66" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="64" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="37" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="71" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="23" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="26" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Eyelid haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="26" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="24" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="28" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="31" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="25"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>1(800) 332-2056</phone>
      <email>Clinical.Trials@bms.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/NCT02985957
org study id: CA209-650
secondary id: 2016-001928-54
nct id: NCT02985957
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate
      cancer (mCRPC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR) Cohorts B and C Per BICR
time frame: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
description: Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).
Confidence-interval based on Clopper Pearson method.
measure: Objective Response Rate (ORR) Cohort D
time frame: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
description: In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.
Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).
Confidence-interval based on Clopper Pearson method.
measure: Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
time frame: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
description: Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.
The following progressive diseases were collected, documented and assessed as below:
Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment
Bone disease progression by Prostate Cancer Working Group (PCWG2)
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).
Based on Kaplan-Meier estimates.
measure: Radiographic Progression-Free Survival (rPFS) for Cohort D
time frame: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
description: Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.
The following progressive diseases were collected, documented and assessed as below:
Radiographic progression per BICR assessment
Bone disease progression by (Prostate Cancer Working Group) PCWG2
Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).
Based on Kaplan-Meier estimates.
measure: Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
time frame: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
description: Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.
Radiographic progression per Investigator assessment:
Bone disease progression by Prostate Cancer Working Group (PCWG2)
Non-bone soft tissue disease progression by RECIST v1.1
Clinical progression per investigator assessment:
Need for palliative radiation therapy involving more than one site, OR
Surgery of kyphoplasty to any neoplastic lesion, OR
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).
Based on Kaplan-Meier estimates.
measure: Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
time frame: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
description: Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.
Radiographic progression per Investigator assessment:
Bone disease progression by Prostate Cancer Working Group (PCWG2)
Non-bone soft tissue disease progression by RECIST v1.1
Clinical progression per investigator assessment:
Need for palliative radiation therapy involving more than one site, OR
Surgery of kyphoplasty to any neoplastic lesion, OR
Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).
Based on Kaplan-Meier estimates.
measure: Overall Survival (OS) Cohorts B and C
time frame: From first dose to the date of death due to any cause (assessed up to approximately 61 months)
description: Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.
Based on Kaplan-Meier estimates.
measure: Overall Survival (OS) Cohort D
time frame: From randomization to the date of death due to any cause (assessed up to approximately 61 months)
description: Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.
Based on Kaplan-Meier estimates.
measure: Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
time frame: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
description: The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Confidence-interval based on Clopper Pearson method.
measure: Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
time frame: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
description: The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Confidence-interval based on Clopper Pearson method.
measure: The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
time frame: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)
description: Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
measure: The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
time frame: From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
description: Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
measure: The Number of Participants Who Died in Cohorts A, B and C
time frame: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).
description: Death due to any cause.
measure: The Number of Participants Who Died in Cohort D
time frame: From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
description: Death due to any cause.
measure: The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.
measure: The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: The number of participants with an change in laboratory values from baseline Grade in Cohort D.
measure: The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
measure: The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.
ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
measure: The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
description: The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
measure: The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
time frame: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
description: The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.
TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
measure: Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
time frame: At baseline and Week 4 (Cycle 2)
description: Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
measure: Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
time frame: At baseline and 4 weeks after first dose.
description: Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
measure: Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
time frame: At baseline and 4 weeks after first dose.
description: The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.
measure: Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
time frame: At baseline and at Week 4 of Cycle 2.
description: The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
measure: Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
time frame: At baseline and 4 weeks after first dose.
description: The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
arm group label: Cohort A (Arm A)
arm group type: Experimental
arm group label: Cohort B (Arm B)
arm group type: Experimental
arm group label: Cohort C (Arm C)
arm group type: Experimental
arm group label: Cohort D (Arm D1)
arm group type: Experimental
arm group label: Cohort D (Arm D2)
arm group type: Experimental
arm group label: Cohort D (Arm D3)
arm group type: Experimental
arm group label: Cohort D (Arm D4)
arm group type: Experimental
intervention type: Biological
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Cohort A (Arm A)
arm group label: Cohort B (Arm B)
arm group label: Cohort C (Arm C)
arm group label: Cohort D (Arm D1)
arm group label: Cohort D (Arm D2)
other name: BMS-936558
other name: Opdivo
intervention type: Biological
intervention name: Ipilimumab
description: Specified dose on specified days
arm group label: Cohort A (Arm A)
arm group label: Cohort B (Arm B)
arm group label: Cohort C (Arm C)
arm group label: Cohort D (Arm D1)
arm group label: Cohort D (Arm D2)
arm group label: Cohort D (Arm D3)
other name: BMS-734016
other name: Yervoy
intervention type: Drug
intervention name: Cabazitaxel
description: Specified dose on specified days
arm group label: Cohort D (Arm D4)
intervention type: Drug
intervention name: Prednisone
description: Specified dose on specified days
arm group label: Cohort D (Arm D4)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Austria
country: Canada
country: Denmark
country: France
country: Germany
country: Italy
country: Poland
country: Spain
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Nivolumab
mesh term: Ipilimumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 