An Investigational Immunotherapy Study of Nivolumab in Co... | NCT03338790

Name	Class
Clovis Oncology, Inc.	INDUSTRY
Astellas Pharma Inc	INDUSTRY

Label	Type	Description	Intervention Names
nivolumab + rucaparib	Experimental	Specified dose on specified days	Biological: nivolumab Drug: rucaparib
nivolumab + docetaxel + prednisone	Experimental	Specified dose on specified days	Biological: nivolumab Drug: docetaxel Drug: prednisone
nivolumab + enzalutamide	Experimental	Specified dose on specified days	Biological: nivolumab Drug: enzalutamide

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Biological	Specified dose on specified days	nivolumab + docetaxel + prednisone nivolumab + enzalutamide nivolumab + rucaparib

Measure	Description	Time Frame
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)	Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease	Up to approximately 36 months
Prostate-Specific Antigen Response Rate (RR-PSA)	Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result	Up to approximately 36 months

Measure	Description	Time Frame
Radiographic Progression-Free Survival (rPFS)	Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)	Up to approximately 84 months

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0036		Daphne	Alabama	36526	United States
Local Institution - 0010

PubMed Identifier	Type	Citation	Retractions
35977756	Derived	Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschabitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vazquez Limon JC, Kwan EM, Castellano D, Flechon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Unsal-Kacmaz K, Wang X, Li J, Loehr A, Pachynski RK. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial. J Immunother Cancer. 2022 Aug;10(8):e004761. doi: 10.1136/jitc-2022-004761.
34802864

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
FG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 8, 2019	Jan 13, 2022

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 Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)

Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease

All response evaluable participants

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 36 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Units	Counts
Participants	OG00058 OG00139 OG00245 OG003

Title	Denominators	Categories
Overall	ParticipantsOG00058 ParticipantsOG00139 ParticipantsOG00245 ParticipantsOG003

Primary

Prostate-Specific Antigen Response Rate (RR-PSA)

Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result

All treated participants with baseline and at least one post-baseline PSA assessment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 36 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Radiographic Progression-Free Survival (rPFS)

Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

All treated participants

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)

Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

All response evaluable participants (CR or PR)

Posted

Median

Full Range

Months

Up to approximately 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)

Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) or death due to any cause

All response evaluable participants (CR or PR)

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C

Secondary

Prostate-Specific Antigen Time to Progression (TTP-PSA)

Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trials working group 3 (PCWG3)

All PSA response evaluable participants

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Overall Survival (OS)

Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up

All treated participants

Posted

Median

95% Confidence Interval

Months

Up to approximately 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Number of Participants With Adverse Events (AEs)

Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)

All treated participants

Posted

Count of Participants

Participants

From first dose to up to 30 days post last dose (Up to 82 months)

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Secondary

Number of Participants Who Died

Number of participants who died due to any cause.

All treated participants

Posted

Count of Participants

Participants

Up to 84 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Units	Counts

Secondary

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
ALP > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN

All treated participant with at least one on-treatment measurement of the corresponding laboratory parameter

Posted

Number

Participants

From first dose to up to 30 days post last dose (up to 82 months)

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen

Secondary

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

TSH value > ULN and
with baseline TSH value <= ULN
with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test.
TSH < LLN and
with baseline TSH value >= LLN
with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test

All treated participants with thyroid stimulating hormone (TSH) abnormality

Posted

Number

Participants

From first dose to up to 30 days post last dose (Up to 82 months)

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen

Secondary

Number of Participants With Laboratory Values Change From Baseline

Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort

All treated participants

Posted

Number

Participants

From first dose to up to 30 days post last dose (Up to 82 months)

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Post-Hoc

Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) - Extended Collection

All response evaluable participants

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 82 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C

Post-Hoc

Prostate-Specific Antigen Response Rate (RR-PSA) - Extended Collection

Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result

All response evaluable participants

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 82 months

ID	Title	Description
OG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
OG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
OG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
OG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0008 affected88 at risk EG0014 affected71 at risk EG0020 affected84 at risk EG0032 affected49 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0011 affected71 at risk EG0024 affected84 at risk EG003
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0011 affected71 at risk EG0024 affected84 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG0020 affected84 at risk EG003
Acute myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Aortic valve stenosis	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Cardiac failure	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG0020 affected84 at risk EG003
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Supraventricular tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Vertigo	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Vertigo positional	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0010 affected71 at risk EG0023 affected84 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Faecaloma	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Haematochezia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Ileus paralytic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Death	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
General physical health deterioration	General disorders and administration site conditions	27.1	Systematic Assessment	EG0003 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Malaise	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Multiple organ dysfunction syndrome	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Sarcoidosis	Immune system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Anal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Atypical pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Biliary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Catheter site cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Cellulitis orbital	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Clostridium difficile infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Diverticulitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Febrile infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Neutropenic infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0002 affected88 at risk EG0019 affected71 at risk EG0026 affected84 at risk EG003
Pulmonary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Rectal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected88 at risk EG0014 affected71 at risk EG0023 affected84 at risk EG003
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Sinusitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected88 at risk EG0013 affected71 at risk EG0021 affected84 at risk EG003
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected88 at risk EG0012 affected71 at risk EG0021 affected84 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG0020 affected84 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Limb injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Ureteric anastomosis complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Vascular anastomosis aneurysm	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0012 affected71 at risk EG0021 affected84 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0013 affected71 at risk EG0021 affected84 at risk EG003
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Electrocardiogram T wave inversion	Investigations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
General physical condition abnormal	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Liver function test abnormal	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Liver function test increased	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0012 affected71 at risk EG0022 affected84 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0013 affected71 at risk EG0020 affected84 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00014 affected88 at risk EG0019 affected71 at risk EG0028 affected84 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected88 at risk EG0013 affected71 at risk EG0020 affected84 at risk EG003
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Basal ganglia infarction	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Cerebrovascular accident	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hyperaesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Nervous system disorder	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Presyncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0012 affected71 at risk EG0020 affected84 at risk EG003
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Trigeminal neuralgia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Device occlusion	Product issues	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Abnormal behaviour	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Confusional state	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Hallucination	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0012 affected71 at risk EG0021 affected84 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG0020 affected84 at risk EG003
Bladder obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0011 affected71 at risk EG0021 affected84 at risk EG003
Hydronephrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Immune-mediated nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Proteinuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Ureteric compression	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Ureteric obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Urinoma	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Testicular mass	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Epiglottic oedema	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0024 affected84 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0012 affected71 at risk EG0021 affected84 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Cutaneous sarcoidosis	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Rash morbilliform	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Haematoma	Vascular disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0011 affected71 at risk EG0020 affected84 at risk EG003
Lymphatic fistula	Vascular disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Lymphoedema	Vascular disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0021 affected84 at risk EG003
Peripheral artery thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0020 affected84 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	EG00032 affected88 at risk EG00130 affected71 at risk EG00225 affected84 at risk EG00315 affected49 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0005 affected88 at risk EG0011 affected71 at risk EG0022 affected84 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00014 affected88 at risk EG0014 affected71 at risk EG00214 affected84 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00011 affected88 at risk EG0018 affected71 at risk EG0022 affected84 at risk EG003
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0015 affected71 at risk EG0024 affected84 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0009 affected88 at risk EG0015 affected71 at risk EG00211 affected84 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0015 affected71 at risk EG0024 affected84 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00026 affected88 at risk EG00118 affected71 at risk EG00221 affected84 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00029 affected88 at risk EG00121 affected71 at risk EG00242 affected84 at risk EG003
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0014 affected71 at risk EG0024 affected84 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00046 affected88 at risk EG00135 affected71 at risk EG00236 affected84 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00030 affected88 at risk EG00118 affected71 at risk EG00214 affected84 at risk EG003
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00024 affected88 at risk EG00112 affected71 at risk EG00217 affected84 at risk EG003
Chills	General disorders and administration site conditions	27.1	Systematic Assessment	EG0004 affected88 at risk EG0016 affected71 at risk EG0029 affected84 at risk EG003
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG00036 affected88 at risk EG00126 affected71 at risk EG00241 affected84 at risk EG003
Mucosal inflammation	General disorders and administration site conditions	27.1	Systematic Assessment	EG0008 affected88 at risk EG0011 affected71 at risk EG0026 affected84 at risk EG003
Oedema peripheral	General disorders and administration site conditions	27.1	Systematic Assessment	EG00017 affected88 at risk EG00115 affected71 at risk EG00220 affected84 at risk EG003
Pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0006 affected88 at risk EG0012 affected71 at risk EG0023 affected84 at risk EG003
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00015 affected88 at risk EG0017 affected71 at risk EG00213 affected84 at risk EG003
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0005 affected88 at risk EG0011 affected71 at risk EG0025 affected84 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0006 affected88 at risk EG0016 affected71 at risk EG0022 affected84 at risk EG003
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected88 at risk EG0014 affected71 at risk EG0025 affected84 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0005 affected88 at risk EG0013 affected71 at risk EG0026 affected84 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected88 at risk EG0015 affected71 at risk EG0026 affected84 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00016 affected88 at risk EG00121 affected71 at risk EG0025 affected84 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00015 affected88 at risk EG00121 affected71 at risk EG0024 affected84 at risk EG003
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG0008 affected88 at risk EG0019 affected71 at risk EG0024 affected84 at risk EG003
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0008 affected88 at risk EG00120 affected71 at risk EG0025 affected84 at risk EG003
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected88 at risk EG0013 affected71 at risk EG0026 affected84 at risk EG003
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0004 affected88 at risk EG0016 affected71 at risk EG0020 affected84 at risk EG003
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0003 affected88 at risk EG0014 affected71 at risk EG0022 affected84 at risk EG003
Weight decreased	Investigations	27.1	Systematic Assessment	EG0009 affected88 at risk EG0017 affected71 at risk EG0026 affected84 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00029 affected88 at risk EG00121 affected71 at risk EG00225 affected84 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0014 affected71 at risk EG0024 affected84 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0012 affected71 at risk EG0026 affected84 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0014 affected71 at risk EG0024 affected84 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0011 affected71 at risk EG0022 affected84 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0015 affected71 at risk EG0021 affected84 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00017 affected88 at risk EG00111 affected71 at risk EG00220 affected84 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00020 affected88 at risk EG00111 affected71 at risk EG00225 affected84 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00012 affected88 at risk EG0017 affected71 at risk EG0028 affected84 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0010 affected71 at risk EG0025 affected84 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0016 affected71 at risk EG0024 affected84 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0006 affected88 at risk EG0013 affected71 at risk EG0021 affected84 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0015 affected71 at risk EG0024 affected84 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0017 affected71 at risk EG00210 affected84 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0022 affected84 at risk EG003
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0016 affected71 at risk EG00217 affected84 at risk EG003
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG00011 affected88 at risk EG0019 affected71 at risk EG00212 affected84 at risk EG003
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0008 affected88 at risk EG0016 affected71 at risk EG00210 affected84 at risk EG003
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0010 affected71 at risk EG00223 affected84 at risk EG003
Paraesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0013 affected71 at risk EG0023 affected84 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0025 affected84 at risk EG003
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0011 affected71 at risk EG0023 affected84 at risk EG003
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0016 affected71 at risk EG0022 affected84 at risk EG003
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG0008 affected88 at risk EG0016 affected71 at risk EG0029 affected84 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0005 affected88 at risk EG0010 affected71 at risk EG0020 affected84 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0013 affected71 at risk EG0025 affected84 at risk EG003
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0003 affected88 at risk EG0013 affected71 at risk EG0025 affected84 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00015 affected88 at risk EG00111 affected71 at risk EG00221 affected84 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00013 affected88 at risk EG0019 affected71 at risk EG00220 affected84 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0010 affected71 at risk EG0025 affected84 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0010 affected71 at risk EG0026 affected84 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG0028 affected84 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0012 affected71 at risk EG00228 affected84 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0005 affected88 at risk EG0015 affected71 at risk EG0023 affected84 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0004 affected88 at risk EG0014 affected71 at risk EG0021 affected84 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected88 at risk EG0010 affected71 at risk EG0027 affected84 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00010 affected88 at risk EG00111 affected71 at risk EG0026 affected84 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00010 affected88 at risk EG0019 affected71 at risk EG00216 affected84 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected88 at risk EG0012 affected71 at risk EG0024 affected84 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected88 at risk EG0014 affected71 at risk EG0021 affected84 at risk EG003
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0005 affected88 at risk EG0013 affected71 at risk EG0025 affected84 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0007 affected88 at risk EG0016 affected71 at risk EG0024 affected84 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
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Arm A1	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
BG001	Arm A2	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
BG002	Arm B	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
BG003	Arm C	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A1: Nivolumab 480 mg and Rucaparib 600 mg	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens	79	88	53	88	87	88
EG001	Arm A2: Nivolumab 480 mg and Rucaparib 600 mg	Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen	66	71	45	71	70	71
EG002	Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2	Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID	76	84	50	84	83	84
EG003	Arm C: Nivolumab 480 mg and Enzalutamide 160 mg	Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD	47	49	25	49	48	49

ID	Term
D000077594	Nivolumab
D000077143	Docetaxel
C540278	enzalutamide
C531549	rucaparib
D011241	Prednisone