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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 : Active, not recruiting
First Posted : May 6, 2013
Results First Posted : May 1, 2019
Last Update Posted : October 14, 2020
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 578
Recruitment Details First patient enrolled 26Aug 2013. Study is ongoing; Data cutoff date of 30May2016 There were 7 patients who were randomized, but did not receive treatment (2 in gBRCA Niraparib; 3 in Non-gBRCA Niraparib and 2 in Non-gBRCA Placebo groups).
Pre-assignment Details  
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non-gBRCA Placebo
Hide Arm/Group Description Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio 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
Period Title: Overall Study
Started [1] 138 65 234 116
Completed [2] 47 4 46 12
Not Completed 91 61 188 104
Reason Not Completed
Adverse Event             17             1             33             2
Withdrawal by Subject             8             8             11             1
Disease Progression             63             49             129             98
Treatment Associated Risk             0             2             2             0
Other Reasons             3             1             11             3
Non Compliance             0             0             2             0
[1]
Enrolled. Note: There were 7 patients who were randomized, but did not receive treatment.
[2]
Patients ongoing at time of data cutoff
Arm/Group Title gBRCA Niraparib gBRCA Placebo Non-gBRCA Niraparib Non- gBRCA Placebo Total
Hide Arm/Group Description Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio 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 Total of all reporting groups
Overall Number of Baseline Participants 138 65 234 116 553
Hide Baseline Analysis Population Description
The baseline analysis population was the intent-to-treat population, defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
110
  79.7%
49
  75.4%
130
  55.6%
69
  59.5%
358
  64.7%
>=65 years
28
  20.3%
16
  24.6%
104
  44.4%
47
  40.5%
195
  35.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
56.9  (9.25) 57.2  (9.24) 62.3  (9.25) 61.3  (9.52) 60.1  (9.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
Female
138
 100.0%
65
 100.0%
234
 100.0%
116
 100.0%
553
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
Hispanic or Latino
4
   2.9%
3
   4.6%
13
   5.6%
3
   2.6%
23
   4.2%
Not Hispanic or Latino
121
  87.7%
57
  87.7%
202
  86.3%
99
  85.3%
479
  86.6%
Unknown or Not Reported
13
   9.4%
5
   7.7%
19
   8.1%
14
  12.1%
51
   9.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
2
   1.4%
3
   4.6%
10
   4.3%
4
   3.4%
19
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.7%
1
   1.5%
4
   1.7%
1
   0.9%
7
   1.3%
White
123
  89.1%
55
  84.6%
201
  85.9%
101
  87.1%
480
  86.8%
More than one race NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
11
   8.0%
6
   9.2%
19
   8.1%
10
   8.6%
46
   8.3%
[1]
Data on multiple race categories not collected
[2]
Total not calculated because data are not available (NA) in one or more arms.
Time to Progression on Penultimate Platinum Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
6 to<12 mo
54
  39.1%
26
  40.0%
90
  38.5%
44
  37.9%
214
  38.7%
>=12 mo
84
  60.9%
39
  60.0%
144
  61.5%
72
  62.1%
339
  61.3%
Best response on Last Platinum Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
Complete response
71
  51.4%
33
  50.8%
117
  50.0%
60
  51.7%
281
  50.8%
Partial response
67
  48.6%
32
  49.2%
117
  50.0%
56
  48.3%
272
  49.2%
Use of Bevacizumab with the penultimate or last platinum regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
Yes
33
  23.9%
17
  26.2%
62
  26.5%
30
  25.9%
142
  25.7%
No
105
  76.1%
48
  73.8%
172
  73.5%
86
  74.1%
411
  74.3%
Previous Lines of Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 65 participants 234 participants 116 participants 553 participants
1
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
2
70
  50.7%
30
  46.2%
155
  66.2%
77
  66.4%
332
  60.0%
>=3
67
  48.6%
35
  53.8%
79
  33.8%
38
  32.8%
219
  39.6%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.2%
1.Primary Outcome
Title Progression-Free Survival (PFS) in Cohort With Germline 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.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
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.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
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 patients 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 (Non-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.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
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 (TFST) in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: months
21.0 [1] 
(17.5 to NA)
8.4
(6.6 to 10.6)
[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.
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 0.31
Confidence Interval (2-Sided) 95%
0.205 to 0.481
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
5.Secondary Outcome
Title Time to First Subsequent Therapy (TFST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
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
11.8
(9.7 to 13.1)
7.2
(5.7 to 8.5)
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.
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 0.55
Confidence Interval (2-Sided) 95%
0.412 to 0.721
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
6.Secondary Outcome
Title Chemotherapy-Free Interval (CFI) in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description CFI 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: months
22.8 [1] 
(17.9 to NA)
9.4
(7.9 to 10.6)
[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.
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 0.26
Confidence Interval (2-Sided) 95%
0.166 to 0.409
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
7.Secondary Outcome
Title Chemotherapy-Free Interval (CFI) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Hide Description CFI 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
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
12.7
(11.0 to 14.7)
8.6
(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 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 0.50
Confidence Interval (2-Sided) 95%
0.370 to 0.666
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
8.Secondary Outcome
Title Progression-Free Survival 2 (PFS2) in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time 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. This study is ongoing, PFS2 is immature at this stage of primary analysis.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 138 65
Median (95% Confidence Interval)
Unit of Measure: months
25.8 [1] 
(20.3 to NA)
19.5 [1] 
(13.3 to NA)
[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 0.0062
Comments Two-sided P-value.
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 0.48
Confidence Interval (2-Sided) 95%
0.280 to 0.821
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
9.Secondary Outcome
Title Progression-Free Survival 2 (PFS2) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time 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. This study is ongoing, PFS2 is immature at this stage of primary analysis.
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.
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Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.
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
18.6
(16.2 to 21.7)
15.6
(13.2 to 20.9)
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 0.0293
Comments Two-sided P-value.
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 0.69
Confidence Interval (2-Sided) 95%
0.494 to 0.964
Estimation Comments Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
10.Secondary Outcome
Title Overall Survival (OS) in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
Time Frame From treatment randomization to date of death by any cause
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Overall Survival (OS) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
Time Frame From treatment randomization to date of death by any cause
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Time to Second Subsequent Therapy (TSST) in Cohort With Germline BRCA Mutation (gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
Time Frame From the date of randomization to the start date of the second subsequent anti-cancer therapy.
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Time to Second Subsequent Therapy (TSST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Hide Description Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
Time Frame From the date of randomization to the start date of the second subsequent anti-cancer therapy.
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 2
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Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 114 55
Mean (Standard Deviation)
Unit of Measure: units 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 (FOSI) in Cohort With Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 109 43
Mean (Standard Deviation)
Unit of Measure: units 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 (FOSI) in Cohort With Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 95 36
Mean (Standard Deviation)
Unit of Measure: units 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 (FOSI) in Cohort With Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Post Progression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 48 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (4.36) -1.2  (4.59)
18.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 181 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (3.78) -0.3  (2.84)
19.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 150 77
Mean (Standard Deviation)
Unit of Measure: units 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 (FOSI) in Cohort With no Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 124 50
Mean (Standard Deviation)
Unit of Measure: units 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 (FOSI) in Cohort With no Germline BRCA
Hide Description The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
Time Frame At Post Progression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 119 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (5.81) -1.8  (4.13)
22.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 118 59
Mean (Standard Deviation)
Unit of Measure: units 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
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 113 44
Mean (Standard Deviation)
Unit of Measure: units 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
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 98 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.002  (0.1119) -0.004  (0.1463)
25.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Post Progression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
Arm/Group Title gBRCA Niraparib gBRCA Placebo
Hide Arm/Group Description:
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Overall Number of Participants Analyzed 49 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.037  (0.1102) -0.014  (0.1623)
26.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 186 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.007  (0.1010) -0.011  (0.1010)
27.Secondary Outcome
Title Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 155 80
Mean (Standard Deviation)
Unit of Measure: units 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
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 127 50
Mean (Standard Deviation)
Unit of Measure: units 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
Hide Description EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients 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). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Time Frame At Post Progression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.
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 121 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.042  (0.1465) -0.052  (0.1354)
Time Frame First day of treatment until 30 days after the last dose (Median days on treatment: Niraparib=250 and Placebo=163)
Adverse Event Reporting Description Incidence of TEAEs were similar in the gBRCAmut and non-gBRCAmut cohorts. Safety data was therefore combined across cohorts for each treatment group to allow for more precise estimates of AE incidence and signal detection.
 
Arm/Group Title Niraparib Placebo
Hide Arm/Group Description Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients. Niraparib vs. Placebo 2:1 ratio Placebo once daily in 28-day cycles until disease progression in patients. Niraparib vs. Placebo 2:1 ratio
All-Cause Mortality
Niraparib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/367 (0.00%)   0/179 (0.00%) 
Hide Serious Adverse Events
Niraparib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   110/367 (29.97%)   27/179 (15.08%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  40/367 (10.90%)  0/179 (0.00%) 
Anaemia * 1  14/367 (3.81%)  0/179 (0.00%) 
Neutropenia * 1  2/367 (0.54%)  0/179 (0.00%) 
Pancytopenia * 1  2/367 (0.54%)  0/179 (0.00%) 
Febrile Neutropenia * 1  1/367 (0.27%)  0/179 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/367 (0.27%)  0/179 (0.00%) 
Cardiac failure * 1  1/367 (0.27%)  0/179 (0.00%) 
Pericardial effusion * 1  1/367 (0.27%)  0/179 (0.00%) 
Sinus Tachycardia * 1  1/367 (0.27%)  0/179 (0.00%) 
Tachycardia * 1  1/367 (0.27%)  0/179 (0.00%) 
Gastrointestinal disorders     
Small intestinal obstruction * 1  5/367 (1.36%)  4/179 (2.23%) 
Constipation * 1  4/367 (1.09%)  1/179 (0.56%) 
Ascites * 1  2/367 (0.54%)  2/179 (1.12%) 
Abdominal pain * 1  2/367 (0.54%)  1/179 (0.56%) 
Intestinal obstruction * 1  2/367 (0.54%)  0/179 (0.00%) 
Subileus * 1  2/367 (0.54%)  0/179 (0.00%) 
Nausea * 1  1/367 (0.27%)  3/179 (1.68%) 
Abdominal hernia * 1  1/367 (0.27%)  0/179 (0.00%) 
Abdominal pain upper * 1  1/367 (0.27%)  0/179 (0.00%) 
Ileus paralytic * 1  1/367 (0.27%)  0/179 (0.00%) 
Impaired gastric emptying * 1  1/367 (0.27%)  0/179 (0.00%) 
Obstruction gastric * 1  1/367 (0.27%)  0/179 (0.00%) 
Vomiting * 1  1/367 (0.27%)  0/179 (0.00%) 
Ileus * 1  0/367 (0.00%)  2/179 (1.12%) 
Abdominal distension * 1  0/367 (0.00%)  1/179 (0.56%) 
Diarrhoea * 1  0/367 (0.00%)  1/179 (0.56%) 
Pancreatitis * 1  0/367 (0.00%)  1/179 (0.56%) 
General disorders     
Pyrexia * 1  3/367 (0.82%)  0/179 (0.00%) 
Disease Progression * 1  2/367 (0.54%)  0/179 (0.00%) 
Non-cardiac chest pain * 1  2/367 (0.54%)  0/179 (0.00%) 
Mucosal inflammation * 1  1/367 (0.27%)  0/179 (0.00%) 
General physical health deterioration * 1  0/367 (0.00%)  1/179 (0.56%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/367 (0.27%)  0/179 (0.00%) 
Cholestasis * 1  1/367 (0.27%)  0/179 (0.00%) 
Hepatic failure * 1  1/367 (0.27%)  0/179 (0.00%) 
Immune system disorders     
Anaphylactoid reaction * 1  1/367 (0.27%)  0/179 (0.00%) 
Infections and infestations     
Urinary tract infection * 1  3/367 (0.82%)  2/179 (1.12%) 
Pneumonia * 1  2/367 (0.54%)  0/179 (0.00%) 
Bronchitis * 1  1/367 (0.27%)  0/179 (0.00%) 
Erysipelas * 1  1/367 (0.27%)  0/179 (0.00%) 
Infection * 1  1/367 (0.27%)  0/179 (0.00%) 
Pyelonephritis * 1  1/367 (0.27%)  0/179 (0.00%) 
Tracheobronchitis * 1  1/367 (0.27%)  0/179 (0.00%) 
Upper respiratory tract infection * 1  1/367 (0.27%)  0/179 (0.00%) 
Wound infection * 1  1/367 (0.27%)  0/179 (0.00%) 
Device related infection * 1  0/367 (0.00%)  1/179 (0.56%) 
Empyema * 1  0/367 (0.00%)  1/179 (0.56%) 
Influenza * 1  0/367 (0.00%)  1/179 (0.56%) 
Injury, poisoning and procedural complications     
Incisional hernia * 1  1/367 (0.27%)  0/179 (0.00%) 
Post procedural discomfort * 1  1/367 (0.27%)  0/179 (0.00%) 
Transfusion reaction * 1  1/367 (0.27%)  0/179 (0.00%) 
Investigations     
Neutrophil count decreased * 1  1/367 (0.27%)  0/179 (0.00%) 
Platelet count decreased * 1  1/367 (0.27%)  0/179 (0.00%) 
Transaminases increased * 1  1/367 (0.27%)  0/179 (0.00%) 
Metabolism and nutrition disorders     
Hypomagnesaemia * 1  1/367 (0.27%)  0/179 (0.00%) 
Type 2 diabetes mellitus * 1  1/367 (0.27%)  0/179 (0.00%) 
Decreased appetite * 1  0/367 (0.00%)  1/179 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome * 1  2/367 (0.54%)  0/179 (0.00%) 
Metastases to peritoneum * 1  1/367 (0.27%)  0/179 (0.00%) 
Undifferentiated sarcoma * 1  1/367 (0.27%)  0/179 (0.00%) 
Metastates to central nervous system * 1  0/367 (0.00%)  2/179 (1.12%) 
Breast Cancer * 1  0/367 (0.00%)  1/179 (0.56%) 
Ovarian cancer recurrent * 1  0/367 (0.00%)  1/179 (0.56%) 
Nervous system disorders     
Depressed level of consciousness * 1  1/367 (0.27%)  0/179 (0.00%) 
Syncope * 1  1/367 (0.27%)  0/179 (0.00%) 
Transient ischaemic attack * 1  1/367 (0.27%)  0/179 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/367 (0.27%)  0/179 (0.00%) 
Hallucination * 1  1/367 (0.27%)  0/179 (0.00%) 
Depression * 1  0/367 (0.00%)  1/179 (0.56%) 
Suicide attempt * 1  0/367 (0.00%)  1/179 (0.56%) 
Renal and urinary disorders     
Acute kidney injury * 1  1/367 (0.27%)  1/179 (0.56%) 
Nephrolithiasis * 1  1/367 (0.27%)  0/179 (0.00%) 
Hydronephrosis * 1  0/367 (0.00%)  1/179 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  3/367 (0.82%)  2/179 (1.12%) 
Dyspnoea * 1  2/367 (0.54%)  0/179 (0.00%) 
Pulmonary embolism * 1  2/367 (0.54%)  0/179 (0.00%) 
Acute pulmonary oedema * 1  1/367 (0.27%)  0/179 (0.00%) 
Asthma * 1  1/367 (0.27%)  0/179 (0.00%) 
Pleuritic pain * 1  1/367 (0.27%)  0/179 (0.00%) 
Pneumonitis * 1  1/367 (0.27%)  0/179 (0.00%) 
Surgical and medical procedures     
Pain management * 1  1/367 (0.27%)  0/179 (0.00%) 
Knee arthroplasty * 1  0/367 (0.00%)  1/179 (0.56%) 
Mastectomy * 1  0/367 (0.00%)  1/179 (0.56%) 
Vascular disorders     
Hypertensive crisis * 1  1/367 (0.27%)  0/179 (0.00%) 
Peripheral artery thrombosis * 1  1/367 (0.27%)  0/179 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Niraparib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   367/367 (100.00%)   171/179 (95.53%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  163/367 (44.41%)  6/179 (3.35%) 
Anaemia * 1  178/367 (48.50%)  12/179 (6.70%) 
Neutropenia * 1  64/367 (17.44%)  6/179 (3.35%) 
Leukopenia * 1  27/367 (7.36%)  9/179 (5.03%) 
Cardiac disorders     
Palpitations * 1  38/367 (10.35%)  3/179 (1.68%) 
Tachycardia * 1  23/367 (6.27%)  2/179 (1.12%) 
Gastrointestinal disorders     
Nausea * 1  270/367 (73.57%)  62/179 (34.64%) 
Constipation * 1  145/367 (39.51%)  35/179 (19.55%) 
Dyspepsia * 1  42/367 (11.44%)  17/179 (9.50%) 
Dry mouth * 1  34/367 (9.26%)  7/179 (3.91%) 
Abdominal Pain * 1  83/367 (22.62%)  52/179 (29.05%) 
Abdominal pain upper * 1  36/367 (9.81%)  15/179 (8.38%) 
Gastrooesophageal reflux disease * 1  23/367 (6.27%)  6/179 (3.35%) 
Vomiting * 1  125/367 (34.06%)  29/179 (16.20%) 
Stomatitis * 1  14/367 (3.81%)  11/179 (6.15%) 
Abdominal distension * 1  28/367 (7.63%)  22/179 (12.29%) 
Diarrhoea * 1  70/367 (19.07%)  37/179 (20.67%) 
General disorders     
Fatigue * 1  168/367 (45.78%)  58/179 (32.40%) 
Asthenia * 1  58/367 (15.80%)  16/179 (8.94%) 
Mucosal inflammation * 1  26/367 (7.08%)  3/179 (1.68%) 
Oedema peripheral * 1  24/367 (6.54%)  8/179 (4.47%) 
Pyrexia * 1  23/367 (6.27%)  10/179 (5.59%) 
Infections and infestations     
Urinary tract infection * 1  36/367 (9.81%)  10/179 (5.59%) 
Bronchitis * 1  19/367 (5.18%)  5/179 (2.79%) 
Nasopharyngitis * 1  41/367 (11.17%)  13/179 (7.26%) 
Upper respiratory tract infection * 1  20/367 (5.45%)  7/179 (3.91%) 
Investigations     
Platelet count decreased * 1  74/367 (20.16%)  4/179 (2.23%) 
Neutrophil count decreased * 1  49/367 (13.35%)  5/179 (2.79%) 
White blood cell count decreased * 1  36/367 (9.81%)  5/179 (2.79%) 
Gamma-glutamyltransferase increased * 1  24/367 (6.54%)  8/179 (4.47%) 
Aspartate aminotransferase increased * 1  20/367 (5.45%)  2/179 (1.12%) 
Blood Creatinine increased * 1  20/367 (5.45%)  6/179 (3.35%) 
Metabolism and nutrition disorders     
Hypomagnesaemia * 1  27/367 (7.36%)  14/179 (7.82%) 
Hypokalaemia * 1  21/367 (5.72%)  8/179 (4.47%) 
Decreased appetite * 1  93/367 (25.34%)  26/179 (14.53%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  49/367 (13.35%)  21/179 (11.73%) 
Arthralgia * 1  43/367 (11.72%)  22/179 (12.29%) 
Myalgia * 1  30/367 (8.17%)  18/179 (10.06%) 
Pain in extremity * 1  25/367 (6.81%)  13/179 (7.26%) 
Muscle spasms * 1  23/367 (6.27%)  6/179 (3.35%) 
Musculoskeletal apin * 1  20/367 (5.45%)  5/179 (2.79%) 
Nervous system disorders     
Headache * 1  95/367 (25.89%)  17/179 (9.50%) 
Dizziness * 1  61/367 (16.62%)  13/179 (7.26%) 
Dysgeusia * 1  37/367 (10.08%)  7/179 (3.91%) 
Neuropathy peripheral * 1  25/367 (6.81%)  12/179 (6.70%) 
Psychiatric disorders     
Anxiety * 1  29/367 (7.90%)  11/179 (6.15%) 
Insomnia * 1  89/367 (24.25%)  13/179 (7.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  55/367 (14.99%)  8/179 (4.47%) 
Dyspnoea * 1  71/367 (19.35%)  15/179 (8.38%) 
Oropharyngeal pain * 1  21/367 (5.72%)  5/179 (2.79%) 
Skin and subcutaneous tissue disorders     
Photosensitivity reaction * 1  32/367 (8.72%)  1/179 (0.56%) 
Alopecia * 1  28/367 (7.63%)  12/179 (6.70%) 
Rash * 1  24/367 (6.54%)  6/179 (3.35%) 
Dry skin * 1  19/367 (5.18%)  7/179 (3.91%) 
Petechiae * 1  19/367 (5.18%)  0/179 (0.00%) 
Pruritus * 1  14/367 (3.81%)  11/179 (6.15%) 
Vascular disorders     
Hypertension * 1  71/367 (19.35%)  8/179 (4.47%) 
Hot flush * 1  32/367 (8.72%)  9/179 (5.03%) 
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Data for progression-free survival 2 (PFS2) was not mature at the data cut for the primary analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officier
Organization: TESARO
Phone: 781-257-2536
EMail: officeofcmo@tesarobio.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: October 14, 2020