A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, o... | NCT02985957

ID	Type	Description	Link
2016-001928-54	EudraCT Number

Status Module

Label	Type	Intervention Names
Cohort A (Arm A)	Experimental	Biological: Nivolumab Biological: Ipilimumab
Cohort B (Arm B)	Experimental	Biological: Nivolumab Biological: Ipilimumab
Cohort C (Arm C)	Experimental	Biological: Nivolumab Biological: Ipilimumab
Cohort D (Arm D1)	Experimental	Biological: Nivolumab Biological: Ipilimumab
Cohort D (Arm D2)	Experimental	Biological: Nivolumab Biological: Ipilimumab
Cohort D (Arm D3)	Experimental	Biological: Ipilimumab
Cohort D (Arm D4)	Experimental

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Cohort A (Arm A) Cohort B (Arm B) Cohort C (Arm C) Cohort D (Arm D1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) Cohorts B and C Per BICR	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.	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)
Objective Response Rate (ORR) Cohort D	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.	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)
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR

Secondary Outcomes

Measure	Description	Time Frame
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C	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.

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0074		Tucson	Arizona	85711	United States
Local Institution - 0046

PubMed Identifier	Type	Citation	Retractions
32916128	Derived	Sharma P, Pachynski RK, Narayan V, Flechon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 1, 2021

Arm/Group Information

ID	Title	Description
BG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
BG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
BG002	Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
BG003	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
BG004	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W	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.
BG005	Cohort D Arm 3: Ipilimumab 3 mg/kg	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.
BG006	Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg	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.
BG007	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR) Cohorts B and C Per BICR

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.

All treated Cohort B and C participants with measurable disease at baseline; pre-specified only to be collected for Cohorts B and C.

Posted

Number

95% Confidence Interval

Percent of Participants

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)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Units	Counts
Participants	OG00032 OG00130

Title

Denominators

Categories

Title	Measurements
	OG00012.5(3.5 to 29.0) OG00120.0(7.7 to 38.6)

Primary

Objective Response Rate (ORR) Cohort D

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.

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.

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.

Posted

Number

95% Confidence Interval

Percent of Participants

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)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Primary

Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR

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.

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.

Posted

Median

95% Confidence Interval

Months

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)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Primary

Radiographic Progression-Free Survival (rPFS) for Cohort D

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.

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.

Posted

Median

95% Confidence Interval

Months

From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Secondary

Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C

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.

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.

Posted

Median

95% Confidence Interval

Months

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)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D

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.

Posted

Median

95% Confidence Interval

Months

From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W

Secondary

Overall Survival (OS) Cohorts B and C

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.

All treated participants in Cohorts B and C; pre-specified only to be collected for Cohorts B and C.

Posted

Median

95% Confidence Interval

Months

From first dose to the date of death due to any cause (assessed up to approximately 61 months)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

Overall Survival (OS) Cohort D

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.

All randomized participants in Cohort D.

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death due to any cause (assessed up to approximately 93 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W	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.

Secondary

Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C

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.

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.

Posted

Number

95% Confidence Interval

Percent of Participants

From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg

Secondary

Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D

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.

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.

Posted

Number

95% Confidence Interval

Percent of Participants

From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 93 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Secondary

The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C

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.

All treated participants in Cohorts A, B and C

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants Experiencing Adverse Events (AEs) in Cohort D

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.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C

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.

All treated participants in Cohorts A, B and C

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D

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.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C

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.

All treated participants in Cohorts A, B and C

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D

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.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C

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.

All treated participants in Cohorts A, B and C.

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D

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.

Posted

Count of Participants

Participants

From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

The Number of Participants Who Died in Cohorts A, B and C

Death due to any cause.

All treated participants in Cohorts A, B and C.

Posted

Count of Participants

Participants

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).

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants Who Died in Cohort D

Death due to any cause.

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.

Posted

Count of Participants

Participants

From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W	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.

Secondary

The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C

The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.

All treated participants in Cohorts A, B and C with baseline laboratory measurements.

Posted

Number

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D

The number of participants with an change in laboratory values from baseline Grade in Cohort D.

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.

Posted

Number

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W	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.

Secondary

The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C

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

All Treated Participants in Cohorts A, B and C with at least one on-treatment liver function measurement.

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D

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

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.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C

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

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.

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.
OG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D

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

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.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.
OG001	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W

Secondary

Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C

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.

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.

Posted

Mean

Full Range

Score on a scale

At baseline and Week 4 (Cycle 2)

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D

All randomized Cohort D participants with baseline and week 4 scores

Posted

Mean

Full Range

Score on a scale

At baseline and 4 weeks after first dose.

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Secondary

Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D

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.

All randomized Cohort D participants with baseline and week 4 scores; pre-specified for data to be collected only from Cohort D participants.

Posted

Mean

Full Range

Score on a scale

At baseline and 4 weeks after first dose.

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Secondary

Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C

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.

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.

Posted

Mean

Full Range

Score on a scale

At baseline and at Week 4 of Cycle 2.

ID	Title	Description
OG000	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.

Secondary

Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D

All randomized Cohort D participants with baseline and week 4 scores

Posted

Mean

Full Range

Score on a scale

At baseline and 4 weeks after first dose.

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Post-Hoc

Objective Response Rate (ORR) Cohort D

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.

Posted

Number

95% Confidence Interval

Percent of Participants

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 93 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Post-Hoc

Radiographic Progression-Free Survival (rPFS) for Cohort D

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.

Posted

Median

95% Confidence Interval

Months

From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)

ID	Title	Description
OG000	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.	2	2	2	2	2	2
EG001	Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.	40	45	37	45	44	45
EG002	Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	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.	41	45	39	45	45	45
EG003	Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W	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.	67	73	44	73	66	73
EG004	Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W	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.	65	74	50	73	64	73
EG005	Cohort D Arm 3: Ipilimumab 3 mg/kg	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.	28	38	25	38	37	38
EG006	Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg	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.	49	74	50	72	71	72
EG007	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3	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.	9	13	9	13	10	13
EG008	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4	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.	21	27	20	27	25	27

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG0030 affected73 at risk EG0041 affected73 at risk EG0050 affected38 at risk EG0060 affected72 at risk EG0070 affected13 at risk EG0080 affected27 at risk
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0020 affected45 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Acute myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0021 affected45 at risk EG003
Atrial flutter	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Atrioventricular block complete	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Cardiac failure	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cardiac failure acute	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cardiac failure congestive	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Myocarditis	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0021 affected45 at risk EG003
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Hypopituitarism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Immune-mediated hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Thyroiditis	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0029 affected45 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0027 affected45 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Enterocolitis haemorrhagic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Large intestinal ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0022 affected45 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Overflow diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Pancreatolithiasis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Terminal ileitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0023 affected45 at risk EG003
Asthenia	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0022 affected45 at risk EG003
Death	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Disease progression	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Fatigue	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0023 affected45 at risk EG003
General physical health deterioration	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pain	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0022 affected45 at risk EG003
Pyrexia	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Sudden death	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Cholecystitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Abscess limb	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Brain abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Clostridium difficile colitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cystitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Cytomegalovirus infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Device related infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Diarrhoea infectious	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Erysipelas	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Eye infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Gastrointestinal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Herpes zoster	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Kidney infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Neutropenic infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Neutropenic sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Osteomyelitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Rectal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Skin infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0022 affected45 at risk EG003
Nerve root injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Postoperative wound complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Shoulder fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Urinary tract procedural complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Wound	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Blood urine present	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Troponin T increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0022 affected45 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0022 affected45 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Malnutrition	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Joint neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Brain oedema	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cerebellar stroke	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cerebral haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cerebrovascular accident	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Embolic stroke	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Facial paralysis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypoaesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Immune-mediated encephalitis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Lethargy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Metabolic encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Myasthenia gravis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Paraparesis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Transient ischaemic attack	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Confusional state	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Delirium	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hallucination	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0023 affected45 at risk EG003
Bladder neck obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Bladder obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Dysuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Hydronephrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Nephrolithiasis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Renal failure	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Ureteric stenosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pelvic pain	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Autoimmune lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Diaphragmalgia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0020 affected45 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0012 affected45 at risk EG0021 affected45 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Circulatory collapse	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Haematoma	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Iliac vein occlusion	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG00113 affected45 at risk EG00214 affected45 at risk EG00310 affected73 at risk EG00415 affected73 at risk EG0059 affected38 at risk EG00626 affected72 at risk EG0074 affected13 at risk EG0086 affected27 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0020 affected45 at risk EG003
Tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Addison's disease	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0024 affected45 at risk EG003
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0021 affected45 at risk EG003
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0016 affected45 at risk EG0029 affected45 at risk EG003
Dry eye	Eye disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Eyelid haematoma	Eye disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Vision blurred	Eye disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0012 affected45 at risk EG0025 affected45 at risk EG003
Abdominal distension	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0024 affected45 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0017 affected45 at risk EG0024 affected45 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0026 affected45 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG00117 affected45 at risk EG00215 affected45 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00123 affected45 at risk EG00228 affected45 at risk EG003
Dry mouth	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0017 affected45 at risk EG0026 affected45 at risk EG003
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0024 affected45 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00113 affected45 at risk EG00219 affected45 at risk EG003
Oral pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0021 affected45 at risk EG003
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0022 affected45 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0018 affected45 at risk EG00216 affected45 at risk EG003
Asthenia	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0027 affected45 at risk EG003
Fatigue	General disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG00128 affected45 at risk EG00231 affected45 at risk EG003
Gait disturbance	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
General physical health deterioration	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0018 affected45 at risk EG0026 affected45 at risk EG003
Pain	General disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0023 affected45 at risk EG003
Pyrexia	General disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0019 affected45 at risk EG00214 affected45 at risk EG003
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Conjunctivitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Extradural abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Intervertebral discitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0022 affected45 at risk EG003
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0024 affected45 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0023 affected45 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Stoma site pruritus	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0024 affected45 at risk EG003
Amylase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0021 affected45 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0016 affected45 at risk EG0022 affected45 at risk EG003
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0024 affected45 at risk EG003
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0024 affected45 at risk EG003
Blood potassium decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Gamma-glutamyltransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
International normalised ratio increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0022 affected45 at risk EG003
Lipase increased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0021 affected45 at risk EG003
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0021 affected45 at risk EG003
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0022 affected45 at risk EG003
Weight decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0029 affected45 at risk EG003
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00115 affected45 at risk EG00229 affected45 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0013 affected45 at risk EG0026 affected45 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0023 affected45 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0023 affected45 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0024 affected45 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0026 affected45 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0025 affected45 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0023 affected45 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00111 affected45 at risk EG00210 affected45 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0019 affected45 at risk EG0023 affected45 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0024 affected45 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0026 affected45 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0014 affected45 at risk EG0023 affected45 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0016 affected45 at risk EG0024 affected45 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0019 affected45 at risk EG0027 affected45 at risk EG003
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0021 affected45 at risk EG003
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0022 affected45 at risk EG003
Polyneuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Presyncope	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0021 affected45 at risk EG003
Tremor	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Agitation	Psychiatric disorders	27.1	Systematic Assessment	EG0002 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0015 affected45 at risk EG0020 affected45 at risk EG003
Confusional state	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0023 affected45 at risk EG003
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0025 affected45 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Dysuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0024 affected45 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0023 affected45 at risk EG003
Nocturia	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0023 affected45 at risk EG003
Pollakiuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0022 affected45 at risk EG003
Urinary incontinence	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected45 at risk EG0021 affected45 at risk EG003
Pelvic pain	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG00113 affected45 at risk EG0028 affected45 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0011 affected45 at risk EG0020 affected45 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0019 affected45 at risk EG0027 affected45 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0013 affected45 at risk EG0021 affected45 at risk EG003
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0021 affected45 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected45 at risk EG0022 affected45 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0014 affected45 at risk EG0022 affected45 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0014 affected45 at risk EG0021 affected45 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0021 affected45 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00112 affected45 at risk EG0026 affected45 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0019 affected45 at risk EG0027 affected45 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG00111 affected45 at risk EG00210 affected45 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0023 affected45 at risk EG003
Flushing	Vascular disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected45 at risk EG0021 affected45 at risk EG003
Hot flush	Vascular disorders	27.1	Systematic Assessment	EG0001 affected2 at risk EG0012 affected45 at risk EG0023 affected45 at risk EG003
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0014 affected45 at risk EG0021 affected45 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected45 at risk EG0024 affected45 at risk EG003
Superficial vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected45 at risk EG0020 affected45 at risk EG003

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Term
D000077594	Nivolumab
D000074324	Ipilimumab
C552428	cabazitaxel
D011241	Prednisone