Trial Outcomes & Findings for Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease (NCT NCT04915755)
NCT ID: NCT04915755
Last Updated: 2025-07-16
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Up to approximately 125 weeks
Results posted on
2025-07-16
Participant Flow
The results presented are based on the data cut-off date of 28 June 2024. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in Post Analysis Continued Treatment (PACT) phase and their data will be reported after they stop receiving treatment as per protocol.
Participant milestones
| Measure |
Niraparib
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
Niraparib
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Ongoing for PACT
|
3
|
2
|
|
Overall Study
Other
|
7
|
11
|
Baseline Characteristics
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
Baseline characteristics by cohort
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 YEARS
STANDARD_DEVIATION 10.03 • n=5 Participants
|
54.3 YEARS
STANDARD_DEVIATION 14.22 • n=7 Participants
|
56.0 YEARS
STANDARD_DEVIATION 12.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
All other races
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
TEAEs
|
18 Participants
|
17 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAEs
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state.Number of participants with TEAEs leading to death were reported.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. Number of participants with TEAEs leading to dose modifications (reduction and interruption/delay) and permanent discontinuation of study treatment were reported.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment
Dose reduction
|
10 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment
Dose interruption/delay
|
11 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment
Permanent discontinuation of study treatment
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population. Only those participants with data available at specified time points have been analyzed.
Number of participants with ECOG Performance Status was reported and was measured on 6-point grade scale 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead. Data is presented as baseline grade, best case on-therapy, and worst-case on-therapy for the available participants.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline, Grade 0
|
16 Participants
|
16 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline, Grade 1
|
2 Participants
|
6 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Worst Case On-therapy, Grade 0
|
7 Participants
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Worst Case On-therapy, Grade 1
|
9 Participants
|
11 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Worst Case On-therapy, Grade 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Worst Case On-therapy, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Best Case On-therapy, Grade 0
|
17 Participants
|
17 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Best Case On-therapy, Grade 1
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population. Only those participants with data available for specified parameter have been analyzed. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Blood samples were collected for the analysis of hematology parameters. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Basophils, To Low
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Basophils, To Normal or No Change
|
12 Participants
|
19 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Basophils, To High
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Eosinophils, To Low
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Eosinophils, To Normal or No Change
|
12 Participants
|
15 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Eosinophils, To High
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Erythrocyte Mean Corpuscular Volume (MCV), To Low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
MCV, To Normal or No Change
|
9 Participants
|
21 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
MCV, To High
|
9 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hematocrit, To Low
|
10 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hematocrit, To Normal or No Change
|
8 Participants
|
15 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hematocrit, To High
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hemoglobin, To Low
|
9 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hemoglobin, To Normal or No Change
|
9 Participants
|
16 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Hemoglobin, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Leukocytes, To Low
|
13 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Leukocytes, To Normal or No Change
|
3 Participants
|
19 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Leukocytes, To High
|
4 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Lymphocytes, To Low
|
9 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Lymphocytes, To Normal or No Change
|
9 Participants
|
21 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Lymphocytes, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Monocytes, To Low
|
5 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Monocytes, To Normal or No Change
|
10 Participants
|
17 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Monocytes, To High
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Neutrophils, To Low
|
9 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Neutrophils, To Normal or No Change
|
8 Participants
|
14 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Neutrophils, To High
|
3 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Platelets, To Low
|
8 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Platelets, To Normal or No Change
|
7 Participants
|
21 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Platelets, To High
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population. Only those participants with data available for specified parameter have been analyzed.Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=21 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Alanine aminotransferase (ALT), To Low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
ALT, To Normal or No Change
|
12 Participants
|
15 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
ALT, To High
|
6 Participants
|
5 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Albumin, To Low
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Albumin, To Normal or No Change
|
15 Participants
|
18 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Albumin, To High
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Alkaline phosphatase (AP), To Low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
AP, To Normal or No Change
|
13 Participants
|
16 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
AP, To High
|
4 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Amylase, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Amylase, To Normal or No Change
|
8 Participants
|
7 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Amylase, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Aspartate aminotransferase (AST), To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
AST, To Normal or No Change
|
12 Participants
|
18 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
AST, To High
|
6 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bicarbonate, To Low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bicarbonate, To Normal or No Change
|
5 Participants
|
9 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bicarbonate, To High
|
6 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bilirubin, To Low
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bilirubin, To Normal or No Change
|
14 Participants
|
18 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Bilirubin, To High
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Calcium, To Low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Calcium, To Normal or No Change
|
12 Participants
|
18 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Calcium, To High
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Carbon Dioxide, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Carbon Dioxide, To Normal or No Change
|
4 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Carbon Dioxide, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Chloride, To Low
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Chloride, To Normal or No Change
|
11 Participants
|
14 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Chloride, To High
|
3 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Creatinine, To Low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Creatinine, To Normal or No Change
|
11 Participants
|
17 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Creatinine, To High
|
6 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Direct Bilirubin, To Low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Direct Bilirubin, To Normal or No Change
|
12 Participants
|
13 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Direct Bilirubin, To High
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Glucose, To Low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Glucose, To Normal or No Change
|
11 Participants
|
13 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Glucose, To High
|
7 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Lipase, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Lipase, To Normal or No Change
|
3 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Lipase, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Magnesium, To Low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Magnesium, To Normal or No Change
|
8 Participants
|
7 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Magnesium, To High
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Phosphate, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Phosphate, To Normal or No Change
|
5 Participants
|
10 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Phosphate, To High
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Potassium, To Low
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Potassium, To Normal or No Change
|
13 Participants
|
16 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Potassium, To High
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Protein, To Low
|
6 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Protein, To Normal or No Change
|
11 Participants
|
17 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Protein, To High
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Sodium, To Low
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Sodium, To Normal or No Change
|
14 Participants
|
19 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Sodium, To High
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urate, To Low
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urate, To Normal or No Change
|
2 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urate, To High
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea, To Low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea, To Normal or No Change
|
10 Participants
|
13 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea, To High
|
5 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea Nitrogen, To Low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea Nitrogen, To Normal or No Change
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Urea Nitrogen, To High
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Safety population. Only those participants with data available for specified parameter have been analyzed.
The abnormal vital sign ranges are: Pulse Rate (PR): Low \[\<60 beats per minute (bpm)\], Normal (60 bpm to 100 bpm), High (\>100 bpm); Temperature: Low (\<35 degree Celsius (°C)), Normal (35 C and 38 C), High (\>38 C); Systolic Blood Pressure (SBP): Low (\<90 millimeter of mercury (mmHg)), Normal (\>90 mmHg to \<120 mmHg), High (\>120 mmHg); Diastolic Blood Pressure (DBP): Low (\<60 mmHg), Normal (60 mmHg to 79 mmHg), High (\>80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
DBP, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
DBP, To within Range or No Change
|
13 Participants
|
22 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
DBP, To High
|
5 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
PR, To Low
|
1 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
PR, To within Range or No Change
|
9 Participants
|
16 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
PR, To High
|
8 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
SBP, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
SBP, To within Range or No Change
|
12 Participants
|
21 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
SBP, To High
|
6 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
Temperature, To Low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
Temperature, To within Range or No Change
|
18 Participants
|
21 Participants
|
|
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
Temperature, To High
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 125 weeksPopulation: Intent-To-Treat Population included all participants randomized into the study.
Number of participants who used concomitant medications is presented.
Outcome measures
| Measure |
Niraparib
n=18 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 Participants
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Number of Participants With Use of Concomitant Medications
|
18 Participants
|
18 Participants
|
Adverse Events
Niraparib
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Niraparib
n=18 participants at risk
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 participants at risk
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Cardiac disorders
Subendocardial ischaemia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Eye disorders
Macular hole
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
Other adverse events
| Measure |
Niraparib
n=18 participants at risk
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to approximately 125 weeks.
|
Placebo
n=22 participants at risk
Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer received Placebo tablet (two or three tablets) orally once a day depending on their body weight and platelet count, throughout each 28-day cycle starting on Cycle 1/Day 1 up to 64.7 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
6/18 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
1/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Constipation
|
44.4%
8/18 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
13.6%
3/22 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
27.3%
6/22 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Glossitis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
27.3%
6/22 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Asthenia
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
18.2%
4/22 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Catheter site pain
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Chest discomfort
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Chest pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Fatigue
|
38.9%
7/18 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
31.8%
7/22 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Influenza like illness
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Malaise
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Mucosal inflammation
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Device related infection
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Diverticulitis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Influenza
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Oral candidiasis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Postoperative wound infection
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
3/18 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Blood cholesterol increased
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Cortisol decreased
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Creatinine renal clearance decreased
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Lymphocyte count decreased
|
11.1%
2/18 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Neutrophil count decreased
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Platelet count decreased
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Investigations
White blood cell count decreased
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Iron overload
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
22.7%
5/22 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
13.6%
3/22 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
18.2%
4/22 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
22.7%
5/22 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Migraine
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Neuralgia
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Psychiatric disorders
Depressed mood
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Renal and urinary disorders
Renal impairment
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Reproductive system and breast disorders
Coital bleeding
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
9.1%
2/22 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.8%
5/18 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Vascular disorders
Hot flush
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
4.5%
1/22 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Vascular disorders
Hypertension
|
33.3%
6/18 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
|
Vascular disorders
Lymphoedema
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
0.00%
0/22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected approximately 125 weeks. The results presented are based on data cut-off date 28 June 2024.
All-cause mortality was reported for all enrolled participants. Safety population included all randomized participants who received at least 1 dose of study treatment (niraparib or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER