NCT04497844 · ADVERSE EVENTS

Adverse events

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) · Source last updated 2026-08-20

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: All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
Other-event reporting threshold: 5%

All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo With Abiraterone Acetate Plus Prednisone Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.	96 / 348	326 / 348	108 / 348
Niraparib With Abiraterone Acetate Plus Prednisone Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.	136 / 347	338 / 347	85 / 348

Group identifiers: EG000: Placebo With Abiraterone Acetate Plus Prednisone · EG001: Niraparib With Abiraterone Acetate Plus Prednisone

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
4
num At Risk
348
group Id
EG001
num Affected
20
num At Risk
347
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
347
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Cardiac Arrest

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
83
num At Risk
348
group Id
EG001
num Affected
178
num At Risk
347
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
18
num At Risk
348
group Id
EG001
num Affected
58
num At Risk
347
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
45
num At Risk
347
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
28
num At Risk
348
group Id
EG001
num Affected
74
num At Risk
347
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
20
num At Risk
348
group Id
EG001
num Affected
66
num At Risk
347
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
21
num At Risk
347
term
Sinus Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
28
num At Risk
347
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
14
num At Risk
348
group Id
EG001
num Affected
21
num At Risk
347
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
57
num At Risk
348
group Id
EG001
num Affected
122
num At Risk
347
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
40
num At Risk
348
group Id
EG001
num Affected
51
num At Risk
347
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
14
num At Risk
348
group Id
EG001
num Affected
22
num At Risk
347
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
20
num At Risk
348
group Id
EG001
num Affected
27
num At Risk
347
term
Dyspepsia

Complete source fields

description

All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.

event Groups

deaths Num Affected
108
deaths Num At Risk
348
description
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
id
EG000
other Num Affected
326
other Num At Risk
348
serious Num Affected
96
serious Num At Risk
348
title
Placebo With Abiraterone Acetate Plus Prednisone
deaths Num Affected
85
deaths Num At Risk
348
description
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
id
EG001
other Num Affected
338
other Num At Risk
347
serious Num Affected
136
serious Num At Risk
347
title
Niraparib With Abiraterone Acetate Plus Prednisone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
83
num At Risk
348
group Id
EG001
num Affected
178
num At Risk
347
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
18
num At Risk
348
group Id
EG001
num Affected
58
num At Risk
347
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
45
num At Risk
347
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
28
num At Risk
348
group Id
EG001
num Affected
74
num At Risk
347
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
20
num At Risk
348
group Id
EG001
num Affected
66
num At Risk
347
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
21
num At Risk
347
term
Sinus Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
28
num At Risk
347
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
14
num At Risk
348
group Id
EG001
num Affected
21
num At Risk
347
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
57
num At Risk
348
group Id
EG001
num Affected
122
num At Risk
347
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
40
num At Risk
348
group Id
EG001
num Affected
51
num At Risk
347
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
14
num At Risk
348
group Id
EG001
num Affected
22
num At Risk
347
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
20
num At Risk
348
group Id
EG001
num Affected
27
num At Risk
347
term
Dyspepsia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
4
num At Risk
348
group Id
EG001
num Affected
20
num At Risk
347
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
347
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
347
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
347
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
348
group Id
EG001
num Affected
2
num At Risk
347
term
Cardiac Arrest

time Frame

All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice