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A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748641
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Results First Posted : October 4, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Castration-Resistant Prostatic Cancer
Interventions Drug: Niraparib
Drug: Abiraterone Acetate
Drug: Prednisone
Drug: Placebo
Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)
Enrollment 765
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
Hide Arm/Group Description Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
Period Title: Overall Study
Started 212 211 123 124 95
Completed 0 0 0 0 0
Not Completed 212 211 123 124 95
Reason Not Completed
Ongoing             155             148             66             79             84
Death             54             59             51             42             9
Lost to Follow-up             0             2             1             0             0
Withdrawal by Subject             3             2             5             3             2
Arm/Group Title Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg Total
Hide Arm/Group Description Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase. Total of all reporting groups
Overall Number of Baseline Participants 212 211 123 124 95 765
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 212 participants 211 participants 123 participants 124 participants 95 participants 765 participants
69.2  (8.79) 68.6  (8.17) 71.2  (7.11) 71.1  (7.52) 69.2  (8.99) 69.7  (8.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 211 participants 123 participants 124 participants 95 participants 765 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
212
 100.0%
211
 100.0%
123
 100.0%
124
 100.0%
95
 100.0%
765
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 211 participants 123 participants 124 participants 95 participants 765 participants
Hispanic or Latino
26
  12.3%
25
  11.8%
8
   6.5%
12
   9.7%
12
  12.6%
83
  10.8%
Not Hispanic or Latino
166
  78.3%
169
  80.1%
110
  89.4%
105
  84.7%
77
  81.1%
627
  82.0%
Unknown or Not Reported
20
   9.4%
17
   8.1%
5
   4.1%
7
   5.6%
6
   6.3%
55
   7.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 211 participants 123 participants 124 participants 95 participants 765 participants
American Indian or Alaska Native
1
   0.5%
1
   0.5%
0
   0.0%
0
   0.0%
1
   1.1%
3
   0.4%
Asian
29
  13.7%
41
  19.4%
45
  36.6%
37
  29.8%
14
  14.7%
166
  21.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
5
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
3
   3.2%
8
   1.0%
White
160
  75.5%
153
  72.5%
72
  58.5%
83
  66.9%
70
  73.7%
538
  70.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
17
   8.0%
16
   7.6%
5
   4.1%
4
   3.2%
7
   7.4%
49
   6.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 212 participants 211 participants 123 participants 124 participants 95 participants 765 participants
ARGENTINA
2
   0.9%
5
   2.4%
2
   1.6%
7
   5.6%
2
   2.1%
18
   2.4%
AUSTRALIA
15
   7.1%
12
   5.7%
12
   9.8%
9
   7.3%
3
   3.2%
51
   6.7%
BELGIUM
5
   2.4%
1
   0.5%
2
   1.6%
3
   2.4%
0
   0.0%
11
   1.4%
BRAZIL
20
   9.4%
14
   6.6%
0
   0.0%
0
   0.0%
10
  10.5%
44
   5.8%
BULGARIA
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
CANADA
4
   1.9%
7
   3.3%
1
   0.8%
4
   3.2%
3
   3.2%
19
   2.5%
CHINA
7
   3.3%
4
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
11
   1.4%
CZECH REPUBLIC
4
   1.9%
3
   1.4%
1
   0.8%
2
   1.6%
1
   1.1%
11
   1.4%
FRANCE
13
   6.1%
12
   5.7%
5
   4.1%
4
   3.2%
3
   3.2%
37
   4.8%
GERMANY
0
   0.0%
4
   1.9%
0
   0.0%
0
   0.0%
5
   5.3%
9
   1.2%
HUNGARY
7
   3.3%
4
   1.9%
3
   2.4%
2
   1.6%
1
   1.1%
17
   2.2%
ISRAEL
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   3.2%
3
   0.4%
ITALY
9
   4.2%
10
   4.7%
3
   2.4%
3
   2.4%
11
  11.6%
36
   4.7%
MALAYSIA
5
   2.4%
10
   4.7%
17
  13.8%
7
   5.6%
1
   1.1%
40
   5.2%
MEXICO
3
   1.4%
2
   0.9%
0
   0.0%
0
   0.0%
0
   0.0%
5
   0.7%
NETHERLANDS
3
   1.4%
4
   1.9%
2
   1.6%
2
   1.6%
0
   0.0%
11
   1.4%
POLAND
12
   5.7%
12
   5.7%
11
   8.9%
15
  12.1%
4
   4.2%
54
   7.1%
PORTUGAL
1
   0.5%
1
   0.5%
0
   0.0%
0
   0.0%
3
   3.2%
5
   0.7%
RUSSIAN FEDERATION
19
   9.0%
21
  10.0%
6
   4.9%
1
   0.8%
3
   3.2%
50
   6.5%
SOUTH KOREA
8
   3.8%
22
  10.4%
21
  17.1%
17
  13.7%
10
  10.5%
78
  10.2%
SPAIN
12
   5.7%
9
   4.3%
9
   7.3%
12
   9.7%
3
   3.2%
45
   5.9%
SWEDEN
4
   1.9%
2
   0.9%
1
   0.8%
1
   0.8%
1
   1.1%
9
   1.2%
TAIWAN
8
   3.8%
4
   1.9%
7
   5.7%
12
   9.7%
3
   3.2%
34
   4.4%
TURKEY
18
   8.5%
16
   7.6%
6
   4.9%
6
   4.8%
5
   5.3%
51
   6.7%
UKRAINE
18
   8.5%
20
   9.5%
12
   9.8%
11
   8.9%
9
   9.5%
70
   9.2%
UNITED KINGDOM
2
   0.9%
1
   0.5%
0
   0.0%
3
   2.4%
3
   3.2%
9
   1.2%
UNITED STATES
12
   5.7%
11
   5.2%
2
   1.6%
3
   2.4%
8
   8.4%
36
   4.7%
1.Primary Outcome
Title Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Hide Description As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.
Time Frame Up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized analysis set for cohort 1 included all randomized participants in Cohort 1. Data for this outcome measure was planned to be collected and analyzed for Cohort 1 only.
Arm/Group Title Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
Hide Arm/Group Description:
Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
Overall Number of Participants Analyzed 212 211
Median (95% Confidence Interval)
Unit of Measure: Months
16.46
(13.83 to 19.38)
13.70
(10.91 to 16.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg, Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0217
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.729
Confidence Interval (2-Sided) 95%
0.556 to 0.956
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cohort 1: Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 97 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Cohort 1: Time to Symptomatic Progression
Hide Description [Not Specified]
Time Frame Up to 97 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Hide Description [Not Specified]
Time Frame Up to 97 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Observed Plasma Concentrations of Niraparib
Hide Description [Not Specified]
Time Frame Up to 97 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Observed Plasma Concentrations of Abiraterone
Hide Description [Not Specified]
Time Frame Up to 97 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Up to 96 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events by Severity
Hide Description [Not Specified]
Time Frame Up to 96 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants With Abnormalities in Laboratory Values
Hide Description [Not Specified]
Time Frame Up to 96 months
Outcome Measure Data Not Reported
Time Frame Up to 32 months
Adverse Event Reporting Description The safety analysis set for Cohort 1 and Cohort 2 included all randomized participants who received at least 1 dose of study drug in Cohort 1 or Cohort 2. The safety analysis set for Cohort 3 included all participants who received at least 1 dose of study drug in Cohort 3.
 
Arm/Group Title Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
Hide Arm/Group Description Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase. Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase. Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
All-Cause Mortality
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/212 (25.94%)   59/211 (27.96%)   53/123 (43.09%)   44/123 (35.77%)   9/95 (9.47%) 
Hide Serious Adverse Events
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   76/212 (35.85%)   52/211 (24.64%)   66/123 (53.66%)   45/123 (36.59%)   21/95 (22.11%) 
Blood and lymphatic system disorders           
Anaemia * 1  12/212 (5.66%)  2/211 (0.95%)  20/123 (16.26%)  2/123 (1.63%)  2/95 (2.11%) 
Leukopenia * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Lymphoid Tissue Hyperplasia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Lymphopenia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Neutropenia * 1  3/212 (1.42%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  1/95 (1.05%) 
Thrombocytopenia * 1  4/212 (1.89%)  0/211 (0.00%)  2/123 (1.63%)  0/123 (0.00%)  0/95 (0.00%) 
Cardiac disorders           
Acute Coronary Syndrome * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Acute Myocardial Infarction * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  1/123 (0.81%)  1/95 (1.05%) 
Angina Pectoris * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Angina Unstable * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Arrhythmia * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Arrhythmia Supraventricular * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Atrial Fibrillation * 1  1/212 (0.47%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Cardiac Arrest * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  2/123 (1.63%)  0/95 (0.00%) 
Cardiac Failure * 1  1/212 (0.47%)  1/211 (0.47%)  3/123 (2.44%)  0/123 (0.00%)  0/95 (0.00%) 
Cardiac Failure Acute * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Cardio-Respiratory Arrest * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Cor Pulmonale * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Coronary Artery Disease * 1  0/212 (0.00%)  2/211 (0.95%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Left Ventricular Dysfunction * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Myocardial Infarction * 1  3/212 (1.42%)  3/211 (1.42%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Myocardial Ischaemia * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Palpitations * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Tachycardia * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Endocrine disorders           
Adrenal Insufficiency * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Eye disorders           
Blindness Unilateral * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Eye Pain * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Gastrointestinal disorders           
Abdominal Mass * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Abdominal Pain * 1  1/212 (0.47%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Abdominal Pain Upper * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Anal Haemorrhage * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Colitis Ischaemic * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Constipation * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Diarrhoea * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Dysphagia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Gastric Ulcer * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Gastritis * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Haematochezia * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Ileus * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Inguinal Hernia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Intestinal Obstruction * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Large Intestinal Obstruction * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Nausea * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Rectal Haemorrhage * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  2/123 (1.63%)  0/95 (0.00%) 
Small Intestinal Obstruction * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Vomiting * 1  0/212 (0.00%)  0/211 (0.00%)  3/123 (2.44%)  0/123 (0.00%)  0/95 (0.00%) 
General disorders           
Adverse Drug Reaction * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Asthenia * 1  1/212 (0.47%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Chest Pain * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Fatigue * 1  2/212 (0.94%)  1/211 (0.47%)  2/123 (1.63%)  1/123 (0.81%)  0/95 (0.00%) 
Gait Disturbance * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
General Physical Health Deterioration * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Multiple Organ Dysfunction Syndrome * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Non-Cardiac Chest Pain * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Oedema Peripheral * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Pain * 1  1/212 (0.47%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Peripheral Swelling * 1  0/212 (0.00%)  0/211 (0.00%)  2/123 (1.63%)  0/123 (0.00%)  0/95 (0.00%) 
Pyrexia * 1  2/212 (0.94%)  1/211 (0.47%)  0/123 (0.00%)  2/123 (1.63%)  0/95 (0.00%) 
Hepatobiliary disorders           
Cholecystitis Chronic * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Hepatic Failure * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Hepatitis Acute * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Jaundice * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Infections and infestations           
Abscess Oral * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Bacteraemia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Bronchitis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  2/123 (1.63%)  0/95 (0.00%) 
Cellulitis * 1  2/212 (0.94%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Clostridium Difficile Infection * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Covid-19 * 1  6/212 (2.83%)  1/211 (0.47%)  3/123 (2.44%)  0/123 (0.00%)  0/95 (0.00%) 
Covid-19 Pneumonia * 1  4/212 (1.89%)  2/211 (0.95%)  0/123 (0.00%)  2/123 (1.63%)  0/95 (0.00%) 
Diverticulitis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Erysipelas * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Escherichia Bacteraemia * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Gastroenteritis * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Infection * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Lower Respiratory Tract Infection * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Medical Device Site Joint Infection * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Meningitis Aseptic * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Pneumonia * 1  7/212 (3.30%)  4/211 (1.90%)  4/123 (3.25%)  2/123 (1.63%)  2/95 (2.11%) 
Post Procedural Sepsis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Pyelonephritis * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Pyelonephritis Acute * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Sepsis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  3/123 (2.44%)  0/95 (0.00%) 
Septic Shock * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Suspected Covid-19 * 1  0/212 (0.00%)  2/211 (0.95%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Tooth Infection * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Urinary Tract Infection * 1  2/212 (0.94%)  2/211 (0.95%)  2/123 (1.63%)  1/123 (0.81%)  2/95 (2.11%) 
Urosepsis * 1  2/212 (0.94%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Injury, poisoning and procedural complications           
Ankle Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Cardiac Valve Rupture * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Fall * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Femoral Neck Fracture * 1  1/212 (0.47%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  1/95 (1.05%) 
Femur Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  2/123 (1.63%)  1/95 (1.05%) 
Hip Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Humerus Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  1/95 (1.05%) 
Lower Limb Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Lumbar Vertebral Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Patella Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Post Procedural Pulmonary Embolism * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Radiation Proctitis * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  1/123 (0.81%)  0/95 (0.00%) 
Road Traffic Accident * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Spinal Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Subdural Haematoma * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Ulna Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Upper Limb Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Vaccination Complication * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Wound Dehiscence * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Investigations           
Aspartate Aminotransferase Increased * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Metabolism and nutrition disorders           
Decreased Appetite * 1  0/212 (0.00%)  0/211 (0.00%)  2/123 (1.63%)  0/123 (0.00%)  0/95 (0.00%) 
Dehydration * 1  2/212 (0.94%)  0/211 (0.00%)  2/123 (1.63%)  0/123 (0.00%)  0/95 (0.00%) 
Diabetes Mellitus Inadequate Control * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Hyperglycaemia * 1  2/212 (0.94%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Hypocalcaemia * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Hypoglycaemia * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Hypokalaemia * 1  2/212 (0.94%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  1/95 (1.05%) 
Hyponatraemia * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Hypophagia * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Type 2 Diabetes Mellitus * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Back Pain * 1  2/212 (0.94%)  1/211 (0.47%)  2/123 (1.63%)  0/123 (0.00%)  1/95 (1.05%) 
Bone Pain * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Fistula * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Musculoskeletal Chest Pain * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Neck Pain * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Osteoarthritis * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  2/123 (1.63%)  0/95 (0.00%) 
Osteonecrosis of Jaw * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Osteoporotic Fracture * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Pathological Fracture * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Acute Myeloid Leukaemia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Adenocarcinoma of Colon * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Basal Cell Carcinoma * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Bladder Cancer * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Bladder Transitional Cell Carcinoma * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Lung Adenocarcinoma Stage I * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Lung Neoplasm Malignant * 1  0/212 (0.00%)  2/211 (0.95%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Squamous Cell Carcinoma of Lung * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Nervous system disorders           
Carotid Artery Stenosis * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Cauda Equina Syndrome * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Cerebral Arteriosclerosis * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Cerebrovascular Accident * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Depressed Level of Consciousness * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Dizziness * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Dysarthria * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Facial Paralysis * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Haemorrhage Intracranial * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  1/123 (0.81%)  0/95 (0.00%) 
Headache * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Hemiparesis * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Ischaemic Cerebral Infarction * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Lumbar Radiculopathy * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Malignant Spinal Cord Compression * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Myelopathy * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Peroneal Nerve Palsy * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Spinal Cord Compression * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Transient Ischaemic Attack * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Vascular Encephalopathy * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Psychiatric disorders           
Completed Suicide * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Renal and urinary disorders           
Acute Kidney Injury * 1  1/212 (0.47%)  2/211 (0.95%)  3/123 (2.44%)  1/123 (0.81%)  1/95 (1.05%) 
Bladder Mass * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Bladder Obstruction * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Bladder Perforation * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Calculus Bladder * 1  2/212 (0.94%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  1/95 (1.05%) 
Chronic Kidney Disease * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Dysuria * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  2/123 (1.63%)  0/95 (0.00%) 
Haematuria * 1  3/212 (1.42%)  1/211 (0.47%)  2/123 (1.63%)  2/123 (1.63%)  1/95 (1.05%) 
Hydronephrosis * 1  0/212 (0.00%)  2/211 (0.95%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Micturition Disorder * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Renal Failure * 1  0/212 (0.00%)  2/211 (0.95%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Renal Impairment * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Ureteric Obstruction * 1  0/212 (0.00%)  0/211 (0.00%)  2/123 (1.63%)  0/123 (0.00%)  0/95 (0.00%) 
Urethral Stenosis * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Urinary Retention * 1  4/212 (1.89%)  2/211 (0.95%)  0/123 (0.00%)  3/123 (2.44%)  0/95 (0.00%) 
Urinary Tract Obstruction * 1  0/212 (0.00%)  1/211 (0.47%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Reproductive system and breast disorders           
Benign Prostatic Hyperplasia * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute Respiratory Failure * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Atelectasis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Dyspnoea * 1  3/212 (1.42%)  0/211 (0.00%)  1/123 (0.81%)  1/123 (0.81%)  0/95 (0.00%) 
Dyspnoea Exertional * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Pleural Effusion * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Pneumothorax * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Pulmonary Embolism * 1  4/212 (1.89%)  1/211 (0.47%)  3/123 (2.44%)  2/123 (1.63%)  3/95 (3.16%) 
Pulmonary Oedema * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Respiratory Failure * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  1/95 (1.05%) 
Skin and subcutaneous tissue disorders           
Actinic Keratosis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Vascular disorders           
Aortic Aneurysm * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Arteriosclerosis * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Circulatory Collapse * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Deep Vein Thrombosis * 1  0/212 (0.00%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Embolism * 1  1/212 (0.47%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Hypertension * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  1/123 (0.81%)  0/95 (0.00%) 
Hypertensive Crisis * 1  0/212 (0.00%)  0/211 (0.00%)  1/123 (0.81%)  0/123 (0.00%)  0/95 (0.00%) 
Hypovolaemic Shock * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  1/95 (1.05%) 
Iliac Artery Rupture * 1  0/212 (0.00%)  0/211 (0.00%)  0/123 (0.00%)  1/123 (0.81%)  0/95 (0.00%) 
Orthostatic Hypotension * 1  1/212 (0.47%)  0/211 (0.00%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
Venous Thrombosis Limb * 1  1/212 (0.47%)  1/211 (0.47%)  0/123 (0.00%)  0/123 (0.00%)  0/95 (0.00%) 
1
Term from vocabulary, MedDRA Version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   198/212 (93.40%)   178/211 (84.36%)   117/123 (95.12%)   108/123 (87.80%)   83/95 (87.37%) 
Blood and lymphatic system disorders           
Anaemia * 1  95/212 (44.81%)  43/211 (20.38%)  59/123 (47.97%)  19/123 (15.45%)  37/95 (38.95%) 
Leukopenia * 1  22/212 (10.38%)  5/211 (2.37%)  7/123 (5.69%)  2/123 (1.63%)  3/95 (3.16%) 
Lymphopenia * 1  19/212 (8.96%)  4/211 (1.90%)  8/123 (6.50%)  4/123 (3.25%)  2/95 (2.11%) 
Neutropenia * 1  28/212 (13.21%)  12/211 (5.69%)  21/123 (17.07%)  6/123 (4.88%)  7/95 (7.37%) 
Thrombocytopenia * 1  45/212 (21.23%)  18/211 (8.53%)  24/123 (19.51%)  3/123 (2.44%)  11/95 (11.58%) 
Gastrointestinal disorders           
Abdominal Distension * 1  8/212 (3.77%)  1/211 (0.47%)  5/123 (4.07%)  2/123 (1.63%)  7/95 (7.37%) 
Abdominal Pain * 1  9/212 (4.25%)  12/211 (5.69%)  2/123 (1.63%)  4/123 (3.25%)  2/95 (2.11%) 
Constipation * 1  65/212 (30.66%)  29/211 (13.74%)  38/123 (30.89%)  25/123 (20.33%)  23/95 (24.21%) 
Diarrhoea * 1  10/212 (4.72%)  8/211 (3.79%)  10/123 (8.13%)  9/123 (7.32%)  5/95 (5.26%) 
Dry Mouth * 1  6/212 (2.83%)  3/211 (1.42%)  5/123 (4.07%)  1/123 (0.81%)  5/95 (5.26%) 
Dyspepsia * 1  13/212 (6.13%)  6/211 (2.84%)  8/123 (6.50%)  7/123 (5.69%)  6/95 (6.32%) 
Gastritis * 1  3/212 (1.42%)  3/211 (1.42%)  7/123 (5.69%)  4/123 (3.25%)  2/95 (2.11%) 
Nausea * 1  50/212 (23.58%)  29/211 (13.74%)  29/123 (23.58%)  20/123 (16.26%)  25/95 (26.32%) 
Vomiting * 1  28/212 (13.21%)  14/211 (6.64%)  17/123 (13.82%)  11/123 (8.94%)  8/95 (8.42%) 
General disorders           
Asthenia * 1  33/212 (15.57%)  19/211 (9.00%)  22/123 (17.89%)  14/123 (11.38%)  12/95 (12.63%) 
Fatigue * 1  56/212 (26.42%)  35/211 (16.59%)  29/123 (23.58%)  21/123 (17.07%)  16/95 (16.84%) 
Oedema Peripheral * 1  20/212 (9.43%)  18/211 (8.53%)  16/123 (13.01%)  15/123 (12.20%)  0/95 (0.00%) 
Pyrexia * 1  12/212 (5.66%)  11/211 (5.21%)  6/123 (4.88%)  3/123 (2.44%)  1/95 (1.05%) 
Infections and infestations           
Upper Respiratory Tract Infection * 1  7/212 (3.30%)  8/211 (3.79%)  7/123 (5.69%)  2/123 (1.63%)  0/95 (0.00%) 
Urinary Tract Infection * 1  19/212 (8.96%)  11/211 (5.21%)  9/123 (7.32%)  5/123 (4.07%)  3/95 (3.16%) 
Injury, poisoning and procedural complications           
Fall * 1  11/212 (5.19%)  25/211 (11.85%)  9/123 (7.32%)  16/123 (13.01%)  4/95 (4.21%) 
Investigations           
Alanine Aminotransferase Increased * 1  10/212 (4.72%)  22/211 (10.43%)  7/123 (5.69%)  11/123 (8.94%)  2/95 (2.11%) 
Aspartate Aminotransferase Increased * 1  11/212 (5.19%)  20/211 (9.48%)  6/123 (4.88%)  12/123 (9.76%)  4/95 (4.21%) 
Blood Alkaline Phosphatase Increased * 1  21/212 (9.91%)  14/211 (6.64%)  9/123 (7.32%)  7/123 (5.69%)  5/95 (5.26%) 
Blood Creatinine Increased * 1  19/212 (8.96%)  8/211 (3.79%)  5/123 (4.07%)  3/123 (2.44%)  7/95 (7.37%) 
Weight Decreased * 1  19/212 (8.96%)  5/211 (2.37%)  20/123 (16.26%)  8/123 (6.50%)  7/95 (7.37%) 
Metabolism and nutrition disorders           
Decreased Appetite * 1  30/212 (14.15%)  13/211 (6.16%)  29/123 (23.58%)  11/123 (8.94%)  13/95 (13.68%) 
Hyperglycaemia * 1  21/212 (9.91%)  18/211 (8.53%)  18/123 (14.63%)  10/123 (8.13%)  5/95 (5.26%) 
Hyperkalaemia * 1  18/212 (8.49%)  12/211 (5.69%)  9/123 (7.32%)  6/123 (4.88%)  5/95 (5.26%) 
Hypokalaemia * 1  27/212 (12.74%)  19/211 (9.00%)  15/123 (12.20%)  9/123 (7.32%)  10/95 (10.53%) 
Hyponatraemia * 1  4/212 (1.89%)  5/211 (2.37%)  2/123 (1.63%)  0/123 (0.00%)  7/95 (7.37%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  28/212 (13.21%)  20/211 (9.48%)  11/123 (8.94%)  20/123 (16.26%)  5/95 (5.26%) 
Back Pain * 1  31/212 (14.62%)  44/211 (20.85%)  19/123 (15.45%)  25/123 (20.33%)  7/95 (7.37%) 
Bone Pain * 1  21/212 (9.91%)  24/211 (11.37%)  10/123 (8.13%)  8/123 (6.50%)  5/95 (5.26%) 
Muscular Weakness * 1  7/212 (3.30%)  4/211 (1.90%)  9/123 (7.32%)  9/123 (7.32%)  2/95 (2.11%) 
Musculoskeletal Chest Pain * 1  4/212 (1.89%)  11/211 (5.21%)  4/123 (3.25%)  7/123 (5.69%)  1/95 (1.05%) 
Pain in Extremity * 1  10/212 (4.72%)  14/211 (6.64%)  9/123 (7.32%)  13/123 (10.57%)  4/95 (4.21%) 
Nervous system disorders           
Dizziness * 1  24/212 (11.32%)  12/211 (5.69%)  13/123 (10.57%)  13/123 (10.57%)  2/95 (2.11%) 
Headache * 1  16/212 (7.55%)  19/211 (9.00%)  3/123 (2.44%)  6/123 (4.88%)  7/95 (7.37%) 
Psychiatric disorders           
Insomnia * 1  22/212 (10.38%)  8/211 (3.79%)  8/123 (6.50%)  7/123 (5.69%)  3/95 (3.16%) 
Renal and urinary disorders           
Haematuria * 1  12/212 (5.66%)  8/211 (3.79%)  7/123 (5.69%)  9/123 (7.32%)  0/95 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  15/212 (7.08%)  10/211 (4.74%)  6/123 (4.88%)  6/123 (4.88%)  2/95 (2.11%) 
Dyspnoea * 1  33/212 (15.57%)  12/211 (5.69%)  15/123 (12.20%)  8/123 (6.50%)  6/95 (6.32%) 
Vascular disorders           
Hot Flush * 1  15/212 (7.08%)  15/211 (7.11%)  6/123 (4.88%)  13/123 (10.57%)  4/95 (4.21%) 
Hypertension * 1  66/212 (31.13%)  44/211 (20.85%)  41/123 (33.33%)  27/123 (21.95%)  15/95 (15.79%) 
1
Term from vocabulary, MedDRA Version 24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director Oncology
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03748641    
Other Study ID Numbers: CR108534
2017-003364-12 ( EudraCT Number )
64091742PCR3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: November 19, 2018
First Posted: November 21, 2018
Results First Submitted: September 8, 2023
Results First Posted: October 4, 2023
Last Update Posted: April 25, 2024