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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847274
Recruitment Status : Completed
First Posted : May 6, 2013
Results First Posted : May 1, 2019
Last Update Posted : June 2, 2023
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
US Oncology Research
Sarah Cannon
Cooperative Ovarian Cancer Group (COGI)
Facing Our Risk of Cancer Empowered
Information provided by (Responsible Party):
Tesaro, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ovarian Neoplasms
Platinum Sensitive Ovarian Cancer
Interventions Drug: Active comparator: Niraparib
Drug: placebo
Enrollment 596
Recruitment Details This was a randomized, double-blind study conducted to analyze maintenance with niraparib versus placebo in participants with ovarian cancer.
Pre-assignment Details A total of 596 participants were enrolled in the study. The results presented are based on the data cut-off date of 31 March 2021 (which aligns with the time of the study unblinding) and the post-unblinding safety data until the end of study (01-April-2021 to 26-December-2021).
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Sub-study: Fasted/Fed FE Sub-study: Fed/Fasted QTc Sub-study: Niraparib gBRCA Niraparib (Post-study Unblinding [PSU]) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Hide Arm/Group Description Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods. Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods. Participants received Niraparib 300 mg once daily orally. Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Period Title: Main Study (Upto 7years 7months 6 Days)
Started 138 65 234 116 0 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0
Not Completed 138 65 234 116 0 0 0 0 0 0 0
Reason Not Completed
Ongoing at the time of analysis             22             8             31             13             0             0             0             0             0             0             0
Withdrawal by Subject             20             11             29             14             0             0             0             0             0             0             0
Lost to Follow-up             7             2             5             1             0             0             0             0             0             0             0
Disease progression             0             0             0             2             0             0             0             0             0             0             0
Subject unblinded by sponsor             12             12             15             14             0             0             0             0             0             0             0
Death             72             29             146             68             0             0             0             0             0             0             0
Other reasons             5             3             8             4             0             0             0             0             0             0             0
Period Title: FE Sub-study, Period1 (Day1)
Started 0 0 0 0 8 9 0 0 0 0 0
Completed 0 0 0 0 8 8 0 0 0 0 0
Not Completed 0 0 0 0 0 1 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             1             0             0             0             0             0
Period Title: FE Sub-study, Washout 1 (Up to Day 7)
Started 0 0 0 0 8 8 0 0 0 0 0
Completed 0 0 0 0 7 8 0 0 0 0 0
Not Completed 0 0 0 0 1 0 0 0 0 0 0
Reason Not Completed
Transferred to Other Arm/Group             0             0             0             0             1             0             0             0             0             0             0
Period Title: FE Sub-study, Period 2 (Day 1)
Started 0 0 0 0 7 8 0 0 0 0 0
Completed 0 0 0 0 7 8 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: QTcSub-study(Upto 5 Year,10 Month,22day)
Started 0 0 0 0 0 0 26 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 26 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             4             0             0             0             0
Death             0             0             0             0             0             0             5             0             0             0             0
Other Reasons             0             0             0             0             0             0             17             0             0             0             0
Period Title: Main Study PSU (Up to 8months, 26days)
Started 0 0 0 0 0 0 0 22 8 31 13
Completed 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 22 8 31 13
Reason Not Completed
Subject Unblinded by Sponsor             0             0             0             0             0             0             0             15             8             18             12
Subject Moved to Rollover Study             0             0             0             0             0             0             0             6             0             9             0
Other reasons             0             0             0             0             0             0             0             1             0             3             1
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             1             0
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Sub-study: Fasted/Fed FE Sub-study: Fed/Fasted QTc Sub-study: Niraparib Total
Hide Arm/Group Description Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods. Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods. Participants received Niraparib 300 mg once daily orally. Total of all reporting groups
Overall Number of Baseline Participants 138 65 234 116 8 9 26 596
Hide Baseline Analysis Population Description
The baseline analysis population was the intent-to-treat population, defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 8 participants 9 participants 26 participants 596 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 64 years
110
  79.7%
49
  75.4%
130
  55.6%
69
  59.5%
5
  62.5%
5
  55.6%
16
  61.5%
384
  64.4%
>=65 years
28
  20.3%
16
  24.6%
104
  44.4%
47
  40.5%
3
  37.5%
4
  44.4%
10
  38.5%
212
  35.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 8 participants 9 participants 26 participants 596 participants
Female
138
 100.0%
65
 100.0%
234
 100.0%
116
 100.0%
8
 100.0%
9
 100.0%
26
 100.0%
596
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 8 participants 9 participants 26 participants 596 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
2
   0.3%
Asian
2
   1.4%
3
   4.6%
10
   4.3%
4
   3.4%
0
   0.0%
0
   0.0%
1
   3.8%
20
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
1
   0.7%
1
   1.5%
4
   1.7%
1
   0.9%
1
  12.5%
0
   0.0%
3
  11.5%
11
   1.8%
White
123
  89.1%
55
  84.6%
201
  85.9%
101
  87.1%
6
  75.0%
9
 100.0%
21
  80.8%
516
  86.6%
Unknown or Not Reported
11
   8.0%
6
   9.2%
19
   8.1%
10
   8.6%
0
   0.0%
0
   0.0%
0
   0.0%
46
   7.7%
1.Primary Outcome
Title Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
Hide Description PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: months
21 [1] 
(12.9 to NA)
5.5
(3.8 to 7.2)
[1]
Upper limit of confidence interval (CI) was not estimable as upper limits of CI for survivor function were above 0.5 (SAS PROC LIFETEST).
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.
Method Log Rank
Comments Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
0.173 to 0.410
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
2.Primary Outcome
Title Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
Hide Description PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCAmut HRD+ Niraparib Non-gBRCAmut HRD+ Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in participants with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 106 56
Median (95% Confidence Interval)
Unit of Measure: months
12.9
(8.1 to 15.9)
3.8
(3.5 to 5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCAmut HRD+ Niraparib, Non-gBRCAmut HRD+ Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested
Method Log Rank
Comments Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.243 to 0.586
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
3.Primary Outcome
Title Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
Hide Description PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
9.3
(7.2 to 11.2)
3.9
(3.7 to 5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.
Method Log Rank
Comments Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.338 to 0.607
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
4.Secondary Outcome
Title Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.
Time Frame From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: Months
19.1
(14.6 to 21.9)
8.6
(6.9 to 12.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Two-sided p-value
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.412 to 0.783
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
Hide Description The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death
Time Frame From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
12.4
(10.9 to 14.5)
7.4
(5.9 to 8.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.454 to 0.740
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
Time Frame From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: Months
20.0
(16.2 to 23.3)
9.4
(7.9 to 10.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.268 to 0.561
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
Hide Description Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
Time Frame From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
13.4
(11.3 to 14.8)
8.7
(6.9 to 10.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.428 to 0.727
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
Time Frame From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: Months
29.9
(24.8 to 33.4)
22.7
(19.5 to 25.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.500 to 0.968
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
Hide Description Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
Time Frame From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
19.5
(17.1 to 22.3)
16.1
(13.6 to 22.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0748
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.627 to 1.022
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Overall survival was defined as the date of randomization to the date of death by any cause.
Time Frame From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: Months
40.9
(34.9 to 52.9)
38.1
(27.6 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3580
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.606 to 1.198
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Overall Survival in Cohort With No Germline BRCA Mutation
Hide Description Overall survival was defined as the date of randomization to the date of death by any cause.
Time Frame From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
31.0
(27.8 to 35.6)
34.8
(27.9 to 41.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6868
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.813 to 1.369
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Time Frame From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: Months
29.7
(23.3 to 33.4)
19.6
(14.4 to 25.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.451 to 0.878
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
Hide Description TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Time Frame From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Median (95% Confidence Interval)
Unit of Measure: Months
20.3
(18.0 to 23.4)
16.7
(14.9 to 21.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1674
Comments Two-sided P-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.654 to 1.077
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 114 55
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.8  (4.58) -0.3  (3.19)
15.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 109 43
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (4.07) -0.3  (3.88)
16.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 95 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.5  (3.77) -0.5  (4.27)
17.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 80 37
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.751  (4.4342) -1.324  (4.5034)
18.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 181 97
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.0  (3.79) -0.3  (2.84)
19.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 150 77
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (4.16) -0.9  (4.23)
20.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 124 50
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (3.76) -0.9  (3.43)
21.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
Hide Description Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 146 82
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.595  (5.5700) -1.801  (4.0290)
22.Secondary Outcome
Title Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 118 59
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.008  (0.1092) -0.008  (0.1354)
23.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 113 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.010  (0.1225) -0.035  (0.1156)
24.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 99 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.002  (0.1116) -0.004  (0.1463)
25.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 81 38
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.041  (0.1192) -0.013  (0.1580)
26.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 185 96
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.007  (0.1013) -0.011  (0.1015)
27.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 155 80
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.004  (0.1077) -0.014  (0.0870)
28.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 127 50
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.005  (0.1097) -0.011  (0.0949)
29.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 149 84
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.047  (0.1355) -0.050  (0.1351)
30.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 138 65
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
47
  34.1%
26
  40.0%
Feet, 1-A little bit
32
  23.2%
12
  18.5%
Feet, 2-Somewhat
24
  17.4%
9
  13.8%
Feet, 3-Quite a bit
21
  15.2%
10
  15.4%
Feet, 4-Very much
9
   6.5%
6
   9.2%
Hands, 0-Not at all
80
  58.0%
37
  56.9%
Hands, 1-A little bit
28
  20.3%
13
  20.0%
Hands, 2-Somewhat
8
   5.8%
6
   9.2%
Hands, 3-Quite a bit
14
  10.1%
5
   7.7%
Hands, 4-Very much
3
   2.2%
2
   3.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7969
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8794
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
31.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 132 64
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
48
  36.4%
25
  39.1%
Feet, 1-A little bit
22
  16.7%
5
   7.8%
Feet, 2-Somewhat
17
  12.9%
15
  23.4%
Feet, 3-Quite a bit
20
  15.2%
10
  15.6%
Feet, 4-Very much
8
   6.1%
3
   4.7%
Hands, 0-Not at all
73
  55.3%
31
  48.4%
Hands, 1-A little bit
19
  14.4%
16
  25.0%
Hands, 2-Somewhat
13
   9.8%
6
   9.4%
Hands, 3-Quite a bit
7
   5.3%
2
   3.1%
Hands, 4-Very much
3
   2.3%
2
   3.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2399
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4584
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
32.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 120 54
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
47
  39.2%
20
  37.0%
Feet, 1-A little bit
22
  18.3%
6
  11.1%
Feet, 2-Somewhat
20
  16.7%
7
  13.0%
Feet, 3-Quite a bit
15
  12.5%
8
  14.8%
Feet, 4-Very much
6
   5.0%
2
   3.7%
Hands, 0-Not at all
70
  58.3%
29
  53.7%
Hands, 1-A little bit
18
  15.0%
6
  11.1%
Hands, 2-Somewhat
16
  13.3%
3
   5.6%
Hands, 3-Quite a bit
4
   3.3%
4
   7.4%
Hands, 4-Very much
2
   1.7%
1
   1.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8566
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4705
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
33.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 105 41
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
44
  41.9%
17
  41.5%
Feet, 1-A little bit
17
  16.2%
5
  12.2%
Feet, 2-Somewhat
13
  12.4%
7
  17.1%
Feet, 3-Quite a bit
15
  14.3%
5
  12.2%
Feet, 4-Very much
9
   8.6%
2
   4.9%
Hands, 0-Not at all
54
  51.4%
21
  51.2%
Hands, 1-A little bit
25
  23.8%
8
  19.5%
Hands, 2-Somewhat
10
   9.5%
4
   9.8%
Hands, 3-Quite a bit
6
   5.7%
2
   4.9%
Hands, 4-Very much
2
   1.9%
1
   2.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8521
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9923
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
34.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame Up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 104 49
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
31
  29.8%
15
  30.6%
Feet, 1-A little bit
20
  19.2%
9
  18.4%
Feet, 2-Somewhat
7
   6.7%
3
   6.1%
Feet, 3-Quite a bit
15
  14.4%
7
  14.3%
Feet, 4-Very much
7
   6.7%
3
   6.1%
Hands, 0-Not at all
44
  42.3%
26
  53.1%
Hands, 1-A little bit
18
  17.3%
4
   8.2%
Hands, 2-Somewhat
8
   7.7%
3
   6.1%
Hands, 3-Quite a bit
7
   6.7%
4
   8.2%
Hands, 4-Very much
3
   2.9%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9997
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection gBRCA Niraparib, gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3518
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
35.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 234 116
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
71
  30.3%
40
  34.5%
Feet, 1-A little bit
58
  24.8%
26
  22.4%
Feet, 2-Somewhat
37
  15.8%
16
  13.8%
Feet, 3-Quite a bit
43
  18.4%
21
  18.1%
Feet, 4-Very much
18
   7.7%
9
   7.8%
Hands, 0-Not at all
120
  51.3%
48
  41.4%
Hands, 1-A little bit
56
  23.9%
37
  31.9%
Hands, 2-Somewhat
28
  12.0%
12
  10.3%
Hands, 3-Quite a bit
15
   6.4%
11
   9.5%
Hands, 4-Very much
8
   3.4%
2
   1.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9367
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2502
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
36.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 2 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 212 113
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
69
  32.5%
32
  28.3%
Feet, 1-A little bit
39
  18.4%
17
  15.0%
Feet, 2-Somewhat
30
  14.2%
12
  10.6%
Feet, 3-Quite a bit
34
  16.0%
18
  15.9%
Feet, 4-Very much
9
   4.2%
8
   7.1%
Hands, 0-Not at all
100
  47.2%
44
  38.9%
Hands, 1-A little bit
38
  17.9%
24
  21.2%
Hands, 2-Somewhat
20
   9.4%
19
  16.8%
Hands, 3-Quite a bit
17
   8.0%
5
   4.4%
Hands, 4-Very much
4
   1.9%
3
   2.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5037
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1640
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
37.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 4 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 181 95
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
54
  29.8%
31
  32.6%
Feet, 1-A little bit
37
  20.4%
16
  16.8%
Feet, 2-Somewhat
34
  18.8%
17
  17.9%
Feet, 3-Quite a bit
20
  11.0%
11
  11.6%
Feet, 4-Very much
9
   5.0%
5
   5.3%
Hands, 0-Not at all
89
  49.2%
43
  45.3%
Hands, 1-A little bit
29
  16.0%
21
  22.1%
Hands, 2-Somewhat
14
   7.7%
10
  10.5%
Hands, 3-Quite a bit
14
   7.7%
3
   3.2%
Hands, 4-Very much
6
   3.3%
1
   1.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9599
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2470
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
38.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame At Cycle 6 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 144 56
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
43
  29.9%
16
  28.6%
Feet, 1-A little bit
29
  20.1%
10
  17.9%
Feet, 2-Somewhat
30
  20.8%
11
  19.6%
Feet, 3-Quite a bit
18
  12.5%
9
  16.1%
Feet, 4-Very much
5
   3.5%
5
   8.9%
Hands, 0-Not at all
68
  47.2%
29
  51.8%
Hands, 1-A little bit
30
  20.8%
10
  17.9%
Hands, 2-Somewhat
13
   9.0%
6
  10.7%
Hands, 3-Quite a bit
9
   6.3%
5
   8.9%
Hands, 4-Very much
3
   2.1%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5921
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7459
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
39.Secondary Outcome
Title Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
Hide Description A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Time Frame Up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 185 105
Measure Type: Count of Participants
Unit of Measure: Participants
Feet, 0-Not at all
57
  30.8%
32
  30.5%
Feet, 1-A little bit
45
  24.3%
12
  11.4%
Feet, 2-Somewhat
23
  12.4%
16
  15.2%
Feet, 3-Quite a bit
19
  10.3%
16
  15.2%
Feet, 4-Very much
5
   2.7%
8
   7.6%
Hands, 0-Not at all
88
  47.6%
48
  45.7%
Hands, 1-A little bit
35
  18.9%
15
  14.3%
Hands, 2-Somewhat
13
   7.0%
9
   8.6%
Hands, 3-Quite a bit
7
   3.8%
10
   9.5%
Hands, 4-Very much
3
   1.6%
1
   1.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0259
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-gBRCA Niraparib, Non-gBRCA Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2798
Comments [Not Specified]
Method Pearson's Chi-squared test
Comments Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
40.Secondary Outcome
Title Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
Hide Description This will never be analyzed since the data for the candidate companion BRAC analysis diagnostic test was not collected which was to be compared with centralized BRCA mutation test used in this study.
Time Frame Up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
41.Secondary Outcome
Title Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
Hide Description This will never be analyzed since the data for the candidate companion HRD diagnostic test was not collected which was to be compared with HRD test used in this study.
Time Frame Up to 7 years, 7 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
42.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.
Time Frame Up to 7 years, 7 months and 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consisted of all participants who ingested any amount of study drug.
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Overall Number of Participants Analyzed 136 65 231 114
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
136
 100.0%
62
  95.4%
231
 100.0%
110
  96.5%
SAEs
51
  37.5%
9
  13.8%
76
  32.9%
20
  17.5%
43.Secondary Outcome
Title Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
Hide Description An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Time Frame Up to 8 months, 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title gBRCA Niraparib (PSU) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Hide Arm/Group Description:
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 1-Apr-2021 to 26-Dec-2021.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Overall Number of Participants Analyzed 22 8 31 13
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
44.Secondary Outcome
Title Number of Participants With Non-serious AEs and SAEs in FE Sub-study
Hide Description An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Time Frame Up to 2 years, 3 months and 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
4
  25.0%
6
  37.5%
SAEs
1
   6.3%
0
   0.0%
45.Secondary Outcome
Title Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
Hide Description An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Time Frame Up to 5 years 10 months and 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title QTc Sub-study: Niraparib
Hide Arm/Group Description:
Participants received Niraparib 300 mg once daily orally.
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
24
  92.3%
SAEs
12
  46.2%
46.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
Hide Description Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.
Time Frame Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population consisted of all participants who received at least one dose of study drug, with sufficient data available to calculate parameters. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: Nanograms*hour per milliliter
29016.1  (18405.23) 31194  (16894.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FE Niraparib Fasted, FE Niraparib Fed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Least square mean
Estimated Value 1.10
Confidence Interval (2-Sided) 90%
0.997 to 1.216
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-last]) Following Administration of Niraparib (FE Sub-study)
Hide Description Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.
Time Frame Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: Nanograms*hour per milliliter
28638.1  (17911.86) 27186.4  (14111.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FE Niraparib Fasted, FE Niraparib Fed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Least square mean
Estimated Value 1.068
Confidence Interval (2-Sided) 90%
0.978 to 1.166
Estimation Comments [Not Specified]
48.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
Hide Description Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.
Time Frame Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
803.7  (403.35) 582.1  (228.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FE Niraparib Fasted, FE Niraparib Fed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Least square mean
Estimated Value 0.785
Confidence Interval (2-Sided) 90%
0.695 to 0.886
Estimation Comments [Not Specified]
49.Secondary Outcome
Title Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
Hide Description Blood samples were collected at indicated time points to analyze the tmax of niraparib.
Time Frame Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 16 15
Median (Full Range)
Unit of Measure: Hour
3.1
(1.7 to 6.1)
6.1
(1.2 to 23)
50.Secondary Outcome
Title Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
Hide Description Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.
Time Frame Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FE Niraparib Fasted FE Niraparib Fed
Hide Arm/Group Description:
Participants received Niraparib 300 mg in fasted condition
Participants received Niraparib 300 mg in fed condition
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: Hour
50.5  (17.87) 47.9  (17.54)
51.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
Hide Description 12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval >450 and <= 480 milliseconds (msec) and >500 msec.
Time Frame At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title QTc Sub-study: Niraparib
Hide Arm/Group Description:
Participants received Niraparib 300 mg once daily orally.
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
>450 msec
2
   7.7%
>480 msec
0
   0.0%
>500 msec
0
   0.0%
Time Frame All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days
Adverse Event Reporting Description Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
 
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Niraparib Fasted FE Niraparib Fed QTc Sub-study: Niraparib gBRCA Niraparib (Post-study Unblinding [PSU]) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Hide Arm/Group Description Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression Participants received Niraparib 300 mg in fasted condition Participants received Niraparib 300 mg in fed condition Participants received Niraparib 300 mg once daily orally. Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021 Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
All-Cause Mortality
gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Niraparib Fasted FE Niraparib Fed QTc Sub-study: Niraparib gBRCA Niraparib (Post-study Unblinding [PSU]) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   72/136 (52.94%)      29/65 (44.62%)      146/231 (63.20%)      68/114 (59.65%)      0/16 (0.00%)      0/16 (0.00%)      5/26 (19.23%)      0/22 (0.00%)      0/8 (0.00%)      0/31 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Niraparib Fasted FE Niraparib Fed QTc Sub-study: Niraparib gBRCA Niraparib (Post-study Unblinding [PSU]) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/136 (37.50%)      9/65 (13.85%)      76/231 (32.90%)      20/114 (17.54%)      1/16 (6.25%)      0/16 (0.00%)      12/26 (46.15%)      0/22 (0.00%)      0/8 (0.00%)      0/31 (0.00%)      0/13 (0.00%)    
Blood and lymphatic system disorders                       
Thrombocytopenia † 1  18/136 (13.24%)  38 0/65 (0.00%)  0 23/231 (9.96%)  36 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 3/26 (11.54%)  9 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/12 (0.00%)  0
Anaemia † 1  4/136 (2.94%)  6 0/65 (0.00%)  0 13/231 (5.63%)  15 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Neutropenia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pancytopenia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 2/231 (0.87%)  3 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Febrile neutropenia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Cardiac disorders                       
Cardiac failure † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Tachycardia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Angina pectoris † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Coronary artery stenosis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pericardial effusion † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Sinus tachycardia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders                       
Small intestinal obstruction † 1  3/136 (2.21%)  3 0/65 (0.00%)  0 6/231 (2.60%)  7 4/114 (3.51%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Ascites † 1  2/136 (1.47%)  2 0/65 (0.00%)  0 0/231 (0.00%)  0 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nausea † 1  1/136 (0.74%)  1 2/65 (3.08%)  2 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal pain † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 1/231 (0.43%)  2 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal pain upper † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Constipation † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 3/231 (1.30%)  3 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Ileus paralytic † 1  1/136 (0.74%)  2 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Intestinal obstruction † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pancreatitis † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/12 (0.00%)  0
Subileus † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 2/231 (0.87%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal hernia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal pain lower † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Gastrooesophageal reflux disease † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Impaired gastric emptying † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Malignant gastrointestinal obstruction † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Obstruction gastric † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Vomiting † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Oesophagitis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Diarrhoea † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Ileus † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal distension † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
General disorders                       
Pyrexia † 1  2/136 (1.47%)  2 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Mucosal inflammation † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Non-cardiac chest pain † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Disease progression † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 2/231 (0.87%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pain † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
General physical health deterioration † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hepatobiliary disorders                       
Cholecystitis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Cholestasis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hepatic failure † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Immune system disorders                       
Anaphylactoid reaction † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations                       
Urinary tract infection † 1  1/136 (0.74%)  1 1/65 (1.54%)  1 2/231 (0.87%)  2 1/114 (0.88%)  1 1/16 (6.25%)  1 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Erysipelas † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Bronchitis † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Infection † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pneumonia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 3/231 (1.30%)  4 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pyelonephritis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Sepsis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Tracheobronchitis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Upper respiratory tract infection † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Wound infection † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Device related infection † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Empyema † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Influenza † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications                       
Hip fracture † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Incisional hernia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Post procedural discomfort † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Transfusion reaction † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Procedural complication † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Product use complaint † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Investigations                       
Neutrophil count decreased † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Troponin increased † 1  0/136 (0.00%)  0 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Platelet count decreased † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 2/231 (0.87%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Transaminases increased † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders                       
Hyperglycaemia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hypomagnesaemia † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Type 2 diabetes mellitus † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Decreased appetite † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Arthropathy † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Acute myeloid leukaemia † 1  6/136 (4.41%)  6 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Myelodysplastic syndrome † 1  5/136 (3.68%)  5 1/65 (1.54%)  1 2/231 (0.87%)  2 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Metastases to central nervous system † 1  1/136 (0.74%)  1 1/65 (1.54%)  1 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Metastases to peritoneum † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Acute erythroid leukaemia † 1  0/136 (0.00%)  0 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Intraductal proliferative breast lesion † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Squamous cell carcinoma † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/0  0 0/0  0 0/0  0 0/0  0
Undifferentiated sarcoma † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Breast cancer † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Ovarian cancer recurrent † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders                       
Depressed level of consciousness † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Syncope † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Transient ischaemic attack † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Product Issues                       
Thrombosis in device † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Psychiatric disorders                       
Anxiety † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Behaviour disorder † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Suicide attempt † 1  0/136 (0.00%)  0 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hallucination † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Depression † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Renal and urinary disorders                       
Acute kidney injury † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nephrolithiasis † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hydronephrosis † 1  0/136 (0.00%)  0 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Urinary tract obstruction † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Acute kidney injury † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Renal failure † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Reproductive system and breast disorders                       
Breast disorder † 1  0/136 (0.00%)  0 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Pleural effusion † 1  1/136 (0.74%)  1 1/65 (1.54%)  1 2/231 (0.87%)  2 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Acute pulmonary oedema † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dyspnoea † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pulmonary embolism † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Respiratory disorder † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Asthma † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pleuritic pain † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pneumonitis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders                       
Hypertensive crisis † 1  1/136 (0.74%)  1 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Peripheral artery thrombosis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 1/231 (0.43%)  1 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo FE Niraparib Fasted FE Niraparib Fed QTc Sub-study: Niraparib gBRCA Niraparib (Post-study Unblinding [PSU]) gBRCA Placebo (PSU) Non-gBRCA Niraparib (PSU) Non-gBRCA Placebo (PSU)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   136/136 (100.00%)      62/65 (95.38%)      231/231 (100.00%)      110/114 (96.49%)      4/16 (25.00%)      6/16 (37.50%)      24/26 (92.31%)      0/22 (0.00%)      0/8 (0.00%)      0/31 (0.00%)      0/13 (0.00%)    
Blood and lymphatic system disorders                       
Anaemia † 1  74/136 (54.41%)  259 5/65 (7.69%)  5 111/231 (48.05%)  328 7/114 (6.14%)  11 1/16 (6.25%)  1 0/16 (0.00%)  0 12/26 (46.15%)  23 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Neutropenia † 1  24/136 (17.65%)  77 3/65 (4.62%)  7 42/231 (18.18%)  128 3/114 (2.63%)  14 0/16 (0.00%)  0 0/16 (0.00%)  0 10/26 (38.46%)  19 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Thrombocytopenia † 1  13/136 (9.56%)  226 2/65 (3.08%)  3 93/231 (40.26%)  256 4/114 (3.51%)  4 0/0  0 0/0  0 13/26 (50.00%)  36 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Leukopenia † 1  11/136 (8.09%)  38 4/65 (6.15%)  6 17/231 (7.36%)  52 5/114 (4.39%)  17 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Cardiac disorders                       
Atrial fibrillation † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Palpitations † 1  14/136 (10.29%)  19 1/65 (1.54%)  1 27/231 (11.69%)  35 4/114 (3.51%)  4 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Tachycardia † 1  11/136 (8.09%)  13 1/65 (1.54%)  1 14/231 (6.06%)  20 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Eye disorders                       
Dry eye † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders                       
Abdominal pain † 1  34/136 (25.00%)  50 17/65 (26.15%)  24 63/231 (27.27%)  93 39/114 (34.21%)  50 0/16 (0.00%)  0 0/16 (0.00%)  0 7/26 (26.92%)  8 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal pain lower † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Ascites † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Constipation † 1  56/136 (41.18%)  105 12/65 (18.46%)  14 96/231 (41.56%)  163 23/114 (20.18%)  30 0/16 (0.00%)  0 1/16 (6.25%)  1 9/26 (34.62%)  12 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Diarrhoea † 1  40/136 (29.41%)  71 15/65 (23.08%)  28 44/231 (19.05%)  76 23/114 (20.18%)  34 1/16 (6.25%)  2 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Flatulence † 1  7/136 (5.15%)  9 3/65 (4.62%)  3 12/231 (5.19%)  17 9/114 (7.89%)  10 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nausea † 1  106/136 (77.94%)  205 23/65 (35.38%)  46 168/231 (72.73%)  304 41/114 (35.96%)  59 0/16 (0.00%)  0 0/16 (0.00%)  0 13/26 (50.00%)  16 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Stomatitis † 1  5/136 (3.68%)  5 4/65 (6.15%)  4 11/231 (4.76%)  18 7/114 (6.14%)  11 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Vomiting † 1  57/136 (41.91%)  96 10/65 (15.38%)  13 74/231 (32.03%)  126 21/114 (18.42%)  31 0/16 (0.00%)  0 1/16 (6.25%)  1 10/26 (38.46%)  11 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal pain upper † 1  17/136 (12.50%)  26 9/65 (13.85%)  12 24/231 (10.39%)  36 9/114 (7.89%)  17 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Abdominal distension † 1  4/136 (2.94%)  6 6/65 (9.23%)  7 23/231 (9.96%)  29 15/114 (13.16%)  17 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dyspepsia † 1  23/136 (16.91%)  37 10/65 (15.38%)  11 22/231 (9.52%)  25 9/114 (7.89%)  10 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dry mouth † 1  19/136 (13.97%)  38 2/6 (33.33%)  5 19/231 (8.23%)  27 5/114 (4.39%)  6 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/0  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Haemorrhoids † 1  7/136 (5.15%)  7 2/65 (3.08%)  2 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Gastrooesophageal reflux disease † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 22/231 (9.52%)  25 4/114 (3.51%)  4 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
General disorders                       
Fatigue † 1  66/136 (48.53%)  134 19/65 (29.23%)  37 110/231 (47.62%)  189 38/114 (33.33%)  53 0/16 (0.00%)  0 1/16 (6.25%)  1 13/26 (50.00%)  20 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Oedema peripheral † 1  12/136 (8.82%)  15 2/65 (3.08%)  3 15/231 (6.49%)  23 6/114 (5.26%)  10 0/16 (0.00%)  0 0/16 (0.00%)  0 5/26 (19.23%)  5 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pain † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Catheter site pain † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Asthenia † 1  27/136 (19.85%)  75 3/65 (4.62%)  3 36/231 (15.58%)  81 13/114 (11.40%)  17 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pyrexia † 1  11/136 (8.09%)  17 4/65 (6.15%)  5 16/231 (6.93%)  23 7/114 (6.14%)  8 0/16 (0.00%)  0 1/16 (6.25%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Influenza like illness † 1  8/136 (5.88%)  11 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Mucosal inflammation † 1  7/136 (5.15%)  9 1/65 (1.54%)  1 19/231 (8.23%)  23 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations                       
Urinary tract infection † 1  20/136 (14.71%)  25 6/65 (9.23%)  11 26/231 (11.26%)  40 5/114 (4.39%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nasopharyngitis † 1  21/136 (15.44%)  33 4/65 (6.15%)  7 29/231 (12.55%)  40 11/114 (9.65%)  17 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Upper respiratory tract infection † 1  15/136 (11.03%)  18 3/65 (4.62%)  5 14/231 (6.06%)  18 4/114 (3.51%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Sinusitis † 1  10/136 (7.35%)  13 1/65 (1.54%)  1 15/231 (6.49%)  19 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Bronchitis † 1  6/136 (4.41%)  8 4/65 (6.15%)  4 15/231 (6.49%)  19 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications                       
Contusion † 1  10/136 (7.35%)  12 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Fall † 1  7/136 (5.15%)  10 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Investigations                       
Blood creatinine increased † 1  11/136 (8.09%)  29 3/65 (4.62%)  4 15/231 (6.49%)  32 3/114 (2.63%)  3 1/16 (6.25%)  1 0/16 (0.00%)  0 4/26 (15.38%)  6 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Gamma-glutamyltransferase increased † 1  7/136 (5.15%)  17 3/65 (4.62%)  3 20/231 (8.66%)  48 5/114 (4.39%)  9 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Neutrophil count decreased † 1  23/136 (16.91%)  64 3/65 (4.62%)  5 31/231 (13.42%)  79 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 4/26 (15.38%)  6 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Platelet count decreased † 1  34/136 (25.00%)  85 1/65 (1.54%)  1 45/231 (19.48%)  132 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 3/26 (11.54%)  8 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
White blood cell count decreased † 1  20/136 (14.71%)  42 5/65 (7.69%)  14 22/231 (9.52%)  64 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  5 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Weight decreased † 1  9/136 (6.62%)  15 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Alanine aminotransferase increased † 1  7/136 (5.15%)  10 0/65 (0.00%)  0 13/231 (5.63%)  21 2/114 (1.75%)  4 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Aspartate aminotransferase increased † 1  7/136 (5.15%)  15 0/65 (0.00%)  0 15/231 (6.49%)  27 2/114 (1.75%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Blood alkaline phosphatase increased † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 13/231 (5.63%)  19 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders                       
Decreased appetite † 1  30/136 (22.06%)  49 9/65 (13.85%)  12 67/231 (29.00%)  94 18/114 (15.79%)  22 1/16 (6.25%)  1 0/16 (0.00%)  0 6/26 (23.08%)  6 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dehydration † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hyperglycaemia † 1  7/136 (5.15%)  8 5/65 (7.69%)  10 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hypokalaemia † 1  11/136 (8.09%)  14 5/65 (7.69%)  10 15/231 (6.49%)  26 4/114 (3.51%)  5 1/16 (6.25%)  1 1/16 (6.25%)  1 4/26 (15.38%)  5 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hypomagnesaemia † 1  15/136 (11.03%)  40 8/65 (12.31%)  18 18/231 (7.79%)  28 6/114 (5.26%)  14 1/16 (6.25%)  1 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Joint swelling † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 3/26 (11.54%)  3 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Arthralgia † 1  29/136 (21.32%)  44 10/65 (15.38%)  11 27/231 (11.69%)  40 14/114 (12.28%)  20 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Back pain † 1  29/136 (21.32%)  40 9/65 (13.85%)  9 33/231 (14.29%)  38 16/114 (14.04%)  38 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pain in extremity † 1  19/136 (13.97%)  27 4/65 (6.15%)  4 16/231 (6.93%)  19 13/114 (11.40%)  14 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Muscle spasms † 1  16/136 (11.76%)  24 2/65 (3.08%)  2 14/231 (6.06%)  15 5/114 (4.39%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Myalgia † 1  15/136 (11.03%)  18 6/65 (9.23%)  7 21/231 (9.09%)  24 12/114 (10.53%)  13 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal pain † 1  11/136 (8.09%)  14 2/65 (3.08%)  2 12/231 (5.19%)  23 3/114 (2.63%)  3 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal chest pain † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 8/231 (3.46%)  9 7/114 (6.14%)  11 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders                       
Amnesia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 3/26 (11.54%)  3 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dizziness † 1  26/136 (19.12%)  39 7/65 (10.77%)  14 43/231 (18.61%)  53 9/114 (7.89%)  12 0/16 (0.00%)  0 0/16 (0.00%)  0 4/26 (15.38%)  5 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Headache † 1  52/136 (38.24%)  76 7/65 (10.77%)  12 52/231 (22.51%)  97 14/114 (12.28%)  21 0/16 (0.00%)  0 0/16 (0.00%)  0 5/26 (19.23%)  7 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Neuropathy peripheral † 1  13/136 (9.56%)  17 4/65 (6.15%)  4 14/231 (6.06%)  19 8/114 (7.02%)  9 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dysgeusia † 1  12/136 (8.82%)  13 1/65 (1.54%)  1 14/231 (6.06%)  18 3/114 (2.63%)  3 0/16 (0.00%)  0 1/16 (6.25%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Paraesthesia † 1  11/136 (8.09%)  31 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Peripheral sensory neuropathy † 1  7/136 (5.15%)  7 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Psychiatric disorders                       
Insomnia † 1  26/136 (19.12%)  36 6/65 (9.23%)  7 67/231 (29.00%)  88 10/114 (8.77%)  11 0/16 (0.00%)  0 0/16 (0.00%)  0 3/26 (11.54%)  3 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Anxiety † 1  12/136 (8.82%)  27 7/65 (10.77%)  11 21/231 (9.09%)  27 5/114 (4.39%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Depression † 1  9/136 (6.62%)  14 2/65 (3.08%)  3 14/231 (6.06%)  21 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%) 
Renal and urinary disorders                       
Dysuria † 1  7/136 (5.15%)  11 1/65 (1.54%)  1 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Cough † 1  26/136 (19.12%)  36 2/65 (3.08%)  4 42/231 (18.18%)  60 8/114 (7.02%)  9 1/16 (6.25%)  1 0/16 (0.00%)  0 4/26 (15.38%)  6 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dyspnoea † 1  23/136 (16.91%)  34 3/65 (4.62%)  4 49/231 (21.21%)  62 12/114 (10.53%)  14 0/16 (0.00%)  0 0/16 (0.00%)  0 4/26 (15.38%)  4 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dysphonia † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Nasal congestion † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Oropharyngeal pain † 1  11/136 (8.09%)  19 2/65 (3.08%)  2 16/231 (6.93%)  21 3/114 (2.63%)  4 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Epistaxis † 1  7/136 (5.15%)  9 0/65 (0.00%)  0 12/231 (5.19%)  15 4/114 (3.51%)  4 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders                       
Rash † 1  14/136 (10.29%)  16 1/65 (1.54%)  1 16/231 (6.93%)  20 5/114 (4.39%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Alopecia † 1  15/136 (11.03%)  17 6/65 (9.23%)  6 20/231 (8.66%)  21 8/114 (7.02%)  9 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Pruritus † 1  12/136 (8.82%)  13 3/65 (4.62%)  3 5/231 (2.16%)  5 8/114 (7.02%)  8 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Photosensitivity reaction † 1  11/136 (8.09%)  13 0/65 (0.00%)  0 25/231 (10.82%)  37 1/114 (0.88%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Petechiae † 1  9/136 (6.62%)  10 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Dry skin † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 18/231 (7.79%)  30 5/114 (4.39%)  7 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders                       
Deep vein thrombosis † 1  0/136 (0.00%)  0 0/65 (0.00%)  0 0/231 (0.00%)  0 0/114 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/26 (7.69%)  2 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hypertension † 1  38/136 (27.94%)  123 5/65 (7.69%)  6 46/231 (19.91%)  207 4/114 (3.51%)  5 0/16 (0.00%)  0 0/16 (0.00%)  0 4/26 (15.38%)  4 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
Hot flush † 1  10/136 (7.35%)  11 3/65 (4.62%)  3 24/231 (10.39%)  43 6/114 (5.26%)  8 0/16 (0.00%)  0 0/16 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/8 (0.00%)  0 0/31 (0.00%)  0 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GSK
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01847274    
Other Study ID Numbers: 213356
PR-30-5011-C ( Other Identifier: Tesaro )
First Submitted: April 11, 2013
First Posted: May 6, 2013
Results First Submitted: October 18, 2018
Results First Posted: May 1, 2019
Last Update Posted: June 2, 2023