Trial Outcomes & Findings for An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (NCT NCT02854436)
NCT ID: NCT02854436
Last Updated: 2025-11-12
Results Overview
ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
289 participants
Primary outcome timeframe
Up to 52 months
Results posted on
2025-11-12
Participant Flow
For long-term extension (LTE) phase, as pre planned in the protocol no efficacy analysis was performed. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
Participant milestones
| Measure |
Niraparib
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Overall Study
STARTED
|
289
|
|
Overall Study
Intent to Treat Participants (Breast Cancer Gene [BRCA] and Non-BRCA Participants)
|
223
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
289
|
Reasons for withdrawal
| Measure |
Niraparib
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
208
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
24
|
|
Overall Study
Other
|
45
|
|
Overall Study
Physician Decision
|
6
|
Baseline Characteristics
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Baseline characteristics by cohort
| Measure |
Niraparib
n=289 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Age, Continuous
|
68.8 years
STANDARD_DEVIATION 7.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
289 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
205 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
51 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
AUSTRALIA
|
31 Participants
n=10 Participants
|
|
Region of Enrollment
BELGIUM
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
BRAZIL
|
12 Participants
n=10 Participants
|
|
Region of Enrollment
CANADA
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21 Participants
n=10 Participants
|
|
Region of Enrollment
DENMARK
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
FRANCE
|
48 Participants
n=10 Participants
|
|
Region of Enrollment
ISRAEL
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
NETHERLANDS
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
SPAIN
|
39 Participants
n=10 Participants
|
|
Region of Enrollment
SWEDEN
|
24 Participants
n=10 Participants
|
|
Region of Enrollment
TAIWAN
|
9 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
17 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED STATES
|
45 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 52 monthsPopulation: Measurable intent to treat (ITT) population also referred to as efficacy analysis set included all participants who received at least 1 dose of study drug and have BRCA (biallelic or germline DNA-repair anomalies) and measurable disease at baseline.
ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
Outcome measures
| Measure |
Niraparib
n=76 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation
|
34.2 percentage of participants
Interval 23.7 to 46.0
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SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: Measurable ITT analysis set included all participants who received at least 1 dose of study drug and have non-BRCA (biallelic DNA-repair anomaly) and measurable disease at baseline.
ORR defined as percentage of participants with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria.
Outcome measures
| Measure |
Niraparib
n=47 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
|
Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
|
10.6 percentage of participants
Interval 3.5 to 23.1
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SECONDARY outcome
Timeframe: At 8 weeks post-baselinePopulation: ITT analysis set included all participants who received at least 1 dose of study drug. Here 'N' (number of participants analysed) specifies the participants with baseline CTC (per 7.5 mL blood) \> 0. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
CTC response rate was defined as the percentage of participants with CTC equals to (=) 0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (\>) 0.
Outcome measures
| Measure |
Niraparib
n=202 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Circulating Tumor Cells (CTC) Response Rate
Non-BRCA
|
8.5 percentage of participants
|
|
Circulating Tumor Cells (CTC) Response Rate
BRCA
|
23.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
OS is defined as time from enrollment to death from any cause.
Outcome measures
| Measure |
Niraparib
n=223 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
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Overall Survival (OS)
BRCA
|
13.01 months
Interval 11.04 to 14.29
|
|
Overall Survival (OS)
Non-BRCA
|
9.63 months
Interval 8.05 to 13.44
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease.
Outcome measures
| Measure |
Niraparib
n=223 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
|
Radiographic Progression-Free Survival (rPFS)
BRCA
|
8.08 months
Interval 5.55 to 8.38
|
|
Radiographic Progression-Free Survival (rPFS)
Non-BRCA
|
3.71 months
Interval 1.97 to 5.49
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Niraparib
n=223 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
|
Time to Radiographic Progression
BRCA
|
8.08 months
Interval 5.75 to 8.97
|
|
Time to Radiographic Progression
Non-BRCA
|
3.78 months
Interval 2.0 to 5.55
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per milliliter (ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
Outcome measures
| Measure |
Niraparib
n=223 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
|
Time to Prostate-Specific Antigen (PSA) Progression
BRCA
|
5.13 months
Interval 4.6 to 5.59
|
|
Time to Prostate-Specific Antigen (PSA) Progression
Non-BRCA
|
3.65 months
Interval 2.83 to 3.71
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture.
Outcome measures
| Measure |
Niraparib
n=223 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
|
|---|---|
|
Time to Symptomatic Skeletal Event (SSE)
BRCA
|
13.80 months
Interval 10.41 to
Here, 'NA' indicates that upper limit of confidence interval was not estimable due to less number of events.
|
|
Time to Symptomatic Skeletal Event (SSE)
Non-BRCA
|
10.35 months
Interval 8.18 to
Here, 'NA' indicates that upper limit of confidence interval was not estimable due to less number of events.
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: Measurable ITT responder analysis set included all participants who received at least 1 dose of study drug, responded to it and have BRCA or non-BRCA and measurable disease at baseline. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) need to initiate any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression.
Outcome measures
| Measure |
Niraparib
n=31 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
|
|---|---|
|
Duration of Objective Response
BRCA
|
5.55 months
Interval 3.91 to 7.2
|
|
Duration of Objective Response
non-BRCA
|
5.16 months
Interval 2.14 to
Here, 'NA' indicates that upper limit of confidence interval was not estimable due to less number of events.
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Outcome measures
| Measure |
Niraparib
n=289 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
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|---|---|
|
Number of Participants With Adverse Events (AEs)
|
288 Participants
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of study drug and with at least one postbaseline assessment for the specific lab test within the time period. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.
Number of participants with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).
Outcome measures
| Measure |
Niraparib
n=283 Participants
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
|
|---|---|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
ALT increased (Grade 1 or 2)
|
67 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
ALT increased (Grade 3 or 4)
|
4 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Alkaline phosphatase increased (Grade 1 or 2)
|
102 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Alkaline phosphatase increased (Grade 3 or 4)
|
7 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
AST increased (Grade 1 or 2)
|
70 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
AST increased (Grade 3 or 4)
|
4 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Blood bilirubin increased (Grade 1 or 2)
|
9 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Blood bilirubin increased (Grade 3 or 4)
|
2 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Creatinine increased (Grade 1 or 2)
|
45 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Creatinine increased (Grade 3 or 4)
|
2 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
GGT increased (Grade 1 or 2)
|
105 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
GGT increased (Grade 3 or 4)
|
14 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Hemoglobin increased (Grade 1 or 2)
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Hemoglobin increased (Grade 3 or 4)
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Lymphocyte count increased (Grade 1 or 2)
|
6 Participants
|
|
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Lymphocyte count increased (Grade 3 or 4)
|
0 Participants
|
Adverse Events
Niraparib
Serious events: 134 serious events
Other events: 280 other events
Deaths: 208 deaths
Serious adverse events
| Measure |
Niraparib
n=289 participants at risk
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
13/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Cardiac disorders
Cardiac Arrest
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Cardiac disorders
Cardiac Failure
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Ascites
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
5/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
5/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Stomatitis
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Volvulus
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
7/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Asthenia
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Facial Pain
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Fatigue
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
General Physical Health Deterioration
|
2.8%
8/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Pain
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Performance Status Decreased
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Pyrexia
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Abdominal Infection
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Abscess Jaw
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Cellulitis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Herpes Zoster
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Infected Lymphocele
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Infection
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Malaria
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Osteomyelitis
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Pneumonia
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Sepsis
|
1.7%
5/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Septic Shock
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Skin Infection
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Spinal Cord Infection
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
3/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Infections and infestations
Urosepsis
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Extradural Haematoma
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Blood Calcium Increased
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Blood Creatinine Increased
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
3/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
7/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.0%
3/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.0%
3/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
1.0%
3/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Altered State of Consciousness
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Headache
|
2.1%
6/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Monoparesis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Nerve Compression
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Paraparesis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Presyncope
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Spinal Cord Compression
|
2.1%
6/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Syncope
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Psychiatric disorders
Confusional State
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Renal and urinary disorders
Haematuria
|
2.1%
6/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Renal and urinary disorders
Renal Impairment
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Renal and urinary disorders
Urinary Retention
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Embolism
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Hypotension
|
0.69%
2/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Phlebitis
|
0.35%
1/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
Other adverse events
| Measure |
Niraparib
n=289 participants at risk
Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
53.3%
154/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.3%
27/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
24/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.7%
54/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.5%
94/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
23/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Constipation
|
33.9%
98/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.6%
48/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.9%
20/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
21/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Nausea
|
57.8%
167/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Stomatitis
|
6.6%
19/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Gastrointestinal disorders
Vomiting
|
37.7%
109/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Asthenia
|
15.6%
45/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Fatigue
|
36.3%
105/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Oedema Peripheral
|
14.2%
41/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
General disorders
Pyrexia
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.9%
20/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
9.0%
26/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Electrocardiogram QT Prolonged
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
8.7%
25/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Investigations
Weight Decreased
|
17.3%
50/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
32.2%
93/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.9%
43/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.4%
59/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
10.4%
30/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.0%
29/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.4%
30/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Dizziness
|
6.6%
19/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Nervous system disorders
Headache
|
10.4%
30/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Psychiatric disorders
Insomnia
|
8.3%
24/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.5%
39/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Hot Flush
|
5.9%
17/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
|
Vascular disorders
Hypertension
|
11.8%
34/289 • Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
|
Additional Information
EXECUTIVE MEDICAL DIRECTOR
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER