NCT02975934 · ADVERSE EVENTS

Adverse events

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency · Source last updated 2025-07-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
Other-event reporting threshold: 5%

All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rucaparib (Treatment Phase) Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.	81 / 270	270 / 270	6 / 270
Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase) Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.	36 / 130	127 / 130	3 / 135
Rucaparib (Cross-over Phase) Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.	18 / 70	67 / 70	1 / 70

Group identifiers: EG000: Rucaparib (Treatment Phase) · EG001: Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase) · EG002: Rucaparib (Cross-over Phase)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
9
num At Risk
270
num Events
9
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
2
num At Risk
70
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
8
num At Risk
130
num Events
11
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
270
num Events
2
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Splenic haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
3
num At Risk
270
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
270
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Ischaemic cardiomyopathy

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
121
num At Risk
270
num Events
435
group Id
EG001
num Affected
24
num At Risk
130
num Events
30
group Id
EG002
num Affected
26
num At Risk
70
num Events
90
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
17
num At Risk
270
num Events
37
group Id
EG001
num Affected
6
num At Risk
130
num Events
6
group Id
EG002
num Affected
4
num At Risk
70
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
270
num Events
44
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
6
num At Risk
70
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
21
num At Risk
270
num Events
23
group Id
EG001
num Affected
10
num At Risk
130
num Events
11
group Id
EG002
num Affected
3
num At Risk
70
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
15
num At Risk
270
num Events
15
group Id
EG001
num Affected
3
num At Risk
130
num Events
4
group Id
EG002
num Affected
3
num At Risk
70
num Events
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
76
num At Risk
270
num Events
101
group Id
EG001
num Affected
19
num At Risk
130
num Events
23
group Id
EG002
num Affected
12
num At Risk
70
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
85
num At Risk
270
num Events
118
group Id
EG001
num Affected
36
num At Risk
130
num Events
49
group Id
EG002
num Affected
10
num At Risk
70
num Events
11
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
18
num At Risk
270
num Events
25
group Id
EG001
num Affected
5
num At Risk
130
num Events
6
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
137
num At Risk
270
num Events
222
group Id
EG001
num Affected
25
num At Risk
130
num Events
44
group Id
EG002
num Affected
26
num At Risk
70
num Events
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
12
num At Risk
270
num Events
20
group Id
EG001
num Affected
10
num At Risk
130
num Events
15
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
65
num At Risk
270
num Events
98
group Id
EG001
num Affected
11
num At Risk
130
num Events
16
group Id
EG002
num Affected
12
num At Risk
70
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
58
num At Risk
270
num Events
136
group Id
EG001
num Affected
20
num At Risk
130
num Events
36
group Id
EG002
num Affected
9
num At Risk
70
num Events
12
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
270
description
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
id
EG000
other Num Affected
270
other Num At Risk
270
serious Num Affected
81
serious Num At Risk
270
title
Rucaparib (Treatment Phase)
deaths Num Affected
3
deaths Num At Risk
135
description
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
id
EG001
other Num Affected
127
other Num At Risk
130
serious Num Affected
36
serious Num At Risk
130
title
Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase)
deaths Num Affected
1
deaths Num At Risk
70
description
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
id
EG002
other Num Affected
67
other Num At Risk
70
serious Num Affected
18
serious Num At Risk
70
title
Rucaparib (Cross-over Phase)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
121
num At Risk
270
num Events
435
group Id
EG001
num Affected
24
num At Risk
130
num Events
30
group Id
EG002
num Affected
26
num At Risk
70
num Events
90
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
17
num At Risk
270
num Events
37
group Id
EG001
num Affected
6
num At Risk
130
num Events
6
group Id
EG002
num Affected
4
num At Risk
70
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
270
num Events
44
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
6
num At Risk
70
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
21
num At Risk
270
num Events
23
group Id
EG001
num Affected
10
num At Risk
130
num Events
11
group Id
EG002
num Affected
3
num At Risk
70
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
15
num At Risk
270
num Events
15
group Id
EG001
num Affected
3
num At Risk
130
num Events
4
group Id
EG002
num Affected
3
num At Risk
70
num Events
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
76
num At Risk
270
num Events
101
group Id
EG001
num Affected
19
num At Risk
130
num Events
23
group Id
EG002
num Affected
12
num At Risk
70
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
85
num At Risk
270
num Events
118
group Id
EG001
num Affected
36
num At Risk
130
num Events
49
group Id
EG002
num Affected
10
num At Risk
70
num Events
11
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
18
num At Risk
270
num Events
25
group Id
EG001
num Affected
5
num At Risk
130
num Events
6
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
137
num At Risk
270
num Events
222
group Id
EG001
num Affected
25
num At Risk
130
num Events
44
group Id
EG002
num Affected
26
num At Risk
70
num Events
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
12
num At Risk
270
num Events
20
group Id
EG001
num Affected
10
num At Risk
130
num Events
15
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
65
num At Risk
270
num Events
98
group Id
EG001
num Affected
11
num At Risk
130
num Events
16
group Id
EG002
num Affected
12
num At Risk
70
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
58
num At Risk
270
num Events
136
group Id
EG001
num Affected
20
num At Risk
130
num Events
36
group Id
EG002
num Affected
9
num At Risk
70
num Events
12
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
9
num At Risk
270
num Events
9
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
2
num At Risk
70
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
8
num At Risk
130
num Events
11
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
270
num Events
2
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Splenic haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
3
num At Risk
270
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
270
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
0
num At Risk
70
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
group Id
EG002
num Affected
1
num At Risk
70
num Events
1
term
Ischaemic cardiomyopathy

time Frame

From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).

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Preserved source evidence · Not medical advice