A Maintenance Study With Niraparib Versus Placebo in Pati... | NCT01847274 | Trialant
NCT01847274
Sponsor
Tesaro, Inc.
Status
Completed
Last Update Posted
Jun 2, 2023Actual
Enrollment
596Actual
Phase
Phase 3
Conditions
Ovarian Neoplasms
Platinum Sensitive Ovarian Cancer
Interventions
Active comparator: Niraparib
placebo
Countries
United States
Austria
Belgium
Canada
Denmark
France
Germany
Hungary
Israel
Italy
Norway
Poland
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01847274
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213356
Secondary IDs
ID
Type
Description
Link
PR-30-5011-C
Other Identifier
Tesaro
Brief Title
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Official Title
A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Acronym
Not provided
Organization
Tesaro, Inc.INDUSTRY
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 21, 2013Actual
Primary Completion Date
Apr 22, 2016Actual
Completion Date
Dec 26, 2021Actual
First Submitted Date
Apr 11, 2013
First Submission Date that Met QC Criteria
May 3, 2013
First Posted Date
May 6, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 18, 2018
Results First Submitted that Met QC Criteria
Apr 10, 2019
Results First Posted Date
May 1, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 31, 2023
Last Update Posted Date
Jun 2, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tesaro, Inc.INDUSTRY
Collaborators
Name
Class
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Myriad Genetics, Inc.
INDUSTRY
US Oncology Research
INDUSTRY
Sarah Cannon
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
Detailed Description
Not provided
Conditions Module
Conditions
Ovarian Neoplasms
Platinum Sensitive Ovarian Cancer
Keywords
ovarian cancer
platinum sensitive
gBRCAmut
BRCA
high-grade serous histology
PARP inhibitor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
596Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Niraparib
Active Comparator
2:1 Ratio administered once daily continuously during a 28 day cycle.
Drug: Active comparator: Niraparib
Placebo
Placebo Comparator
Administered once daily continuously over a 28 day cycle.
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Active comparator: Niraparib
Drug
Niraparib vs placebo 2:1 ratio
Niraparib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
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.
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
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
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.
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
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
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.
Secondary Outcomes
Measure
Description
Time Frame
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
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.
From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
18 years of age or older, female, any race
Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
High grade (or grade 3) serous histology or known to have gBRCAmut
Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
ECOG 0-1
Adequate bone marrow, kidney and liver function
Exclusion Criteria:
Known hypersensitivity to the components of niraparib
Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
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).
Recruitment Details
This was a randomized, double-blind study conducted to analyze maintenance with niraparib versus placebo in participants with ovarian cancer.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
gBRCA Niraparib
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.
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
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
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
From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
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
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
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
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
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
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
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.
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
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
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.
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
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Overall survival was defined as the date of randomization to the date of death by any cause.
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With No Germline BRCA Mutation
Overall survival was defined as the date of randomization to the date of death by any cause.
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
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
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
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
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
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.
Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
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.
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
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.
Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
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.
Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
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.
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
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.
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
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.
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
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.
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
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.
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
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.
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
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.
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
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.
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
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.
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
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.
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
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.
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
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.
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
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.
At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
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").
At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
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").
At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
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").
At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
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").
Up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
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.
At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
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").
At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
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").
At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
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").
At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
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").
Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
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.
Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
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.
Up to 7 years, 7 months and 4 days
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
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.
Up to 7 years, 7 months and 6 days
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
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
Up to 8 months, 26 days
Number of Participants With Non-serious AEs and SAEs in FE Sub-study
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.
Up to 2 years, 3 months and 11 days
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
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.
Up to 5 years 10 months and 22 days
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.
Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
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)
Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the tmax of niraparib.
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
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.
At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
Tucson
Arizona
85704
United States
GSK Investigational Site
Los Angeles
California
90027
United States
GSK Investigational Site
Los Angeles
California
90048
United States
GSK Investigational Site
Palo Alto
California
94304
United States
GSK Investigational Site
San Francisco
California
94109
United States
GSK Investigational Site
New Haven
Connecticut
06510
United States
GSK Investigational Site
Sarasota
Florida
34232
United States
GSK Investigational Site
Tampa
Florida
33612
United States
GSK Investigational Site
Atlanta
Georgia
30342
United States
GSK Investigational Site
Chicago
Illinois
60611
United States
GSK Investigational Site
Indianapolis
Indiana
46202
United States
GSK Investigational Site
Indianapolis
Indiana
46260
United States
GSK Investigational Site
Boston
Massachusetts
02115
United States
GSK Investigational Site
Boston
Massachusetts
02215
United States
GSK Investigational Site
Burlington
Massachusetts
01805
United States
GSK Investigational Site
Minneapolis
Minnesota
55404
United States
GSK Investigational Site
Minneapolis
Minnesota
55455
United States
GSK Investigational Site
Rochester
Minnesota
55905
United States
GSK Investigational Site
Morristown
New Jersey
07962-1956
United States
GSK Investigational Site
Farmington
New Mexico
87401
United States
GSK Investigational Site
Lake Success
New York
11042
United States
GSK Investigational Site
New York
New York
10016
United States
GSK Investigational Site
New York
New York
10065
United States
GSK Investigational Site
Durham
North Carolina
27710
United States
GSK Investigational Site
Oklahoma City
Oklahoma
73104
United States
GSK Investigational Site
Vancouver
Oregon
98684
United States
GSK Investigational Site
Abington
Pennsylvania
19001-3788
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19111
United States
GSK Investigational Site
Providence
Rhode Island
02905
United States
GSK Investigational Site
Nashville
Tennessee
37203
United States
GSK Investigational Site
Austin
Texas
78731
United States
GSK Investigational Site
Dallas
Texas
75390
United States
GSK Investigational Site
Fort Worth
Texas
76104
United States
GSK Investigational Site
The Woodlands
Texas
77380
United States
GSK Investigational Site
Graz
A-8036
Austria
GSK Investigational Site
Innsbruck
A-6020
Austria
GSK Investigational Site
Vienna
1090
Austria
GSK Investigational Site
Edegem
2650
Belgium
GSK Investigational Site
Kortrijk
8500
Belgium
GSK Investigational Site
Leuven
3000
Belgium
GSK Investigational Site
Liège
4000
Belgium
GSK Investigational Site
Calgary
Alberta
T2N 4N2
Canada
GSK Investigational Site
Kelowna
British Columbia
V1Y 5L3
Canada
GSK Investigational Site
Vancouver
British Columbia
V5Z 4E6
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2M9
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4M1
Canada
GSK Investigational Site
Montreal
Quebec
H3T 1E2
Canada
GSK Investigational Site
Montreal
Quebec
H4A 3J1
Canada
GSK Investigational Site
Sherbrooke
Quebec
J1H 5N4
Canada
GSK Investigational Site
Aalborg
9100
Denmark
GSK Investigational Site
Copenhagen
DK-2100
Denmark
GSK Investigational Site
Herlev
DK-2730
Denmark
GSK Investigational Site
Odense
5000
Denmark
GSK Investigational Site
Besançon
25030
France
GSK Investigational Site
Lille
59000
France
GSK Investigational Site
Montpellier
34298
France
GSK Investigational Site
Nice
06189
France
GSK Investigational Site
Saint-Brieuc
22015 cedex
France
GSK Investigational Site
Saint-Herblain
44805
France
GSK Investigational Site
Heidelberg
Baden-Wurttemberg
69120
Germany
GSK Investigational Site
Munich
Bavaria
81377
Germany
GSK Investigational Site
Göttingen
Lower Saxony
37075
Germany
GSK Investigational Site
Hanover
Lower Saxony
30177
Germany
GSK Investigational Site
Düsseldorf
North Rhine-Westphalia
40217
Germany
GSK Investigational Site
Essen
North Rhine-Westphalia
45122
Germany
GSK Investigational Site
Essen
North Rhine-Westphalia
45136
Germany
GSK Investigational Site
Dresden
Saxony
01307
Germany
GSK Investigational Site
Kiel
Schleswig-Holstein
24105
Germany
GSK Investigational Site
Berlin
13353
Germany
GSK Investigational Site
Hamburg
20246
Germany
GSK Investigational Site
Szolnok
5004
Hungary
GSK Investigational Site
Haifa
3109601
Israel
GSK Investigational Site
Holon
58100
Israel
GSK Investigational Site
Jerusalem
91031
Israel
GSK Investigational Site
Jerusalem
91120
Israel
GSK Investigational Site
Kfar Saba
44281
Israel
GSK Investigational Site
Rehovot
76100
Israel
GSK Investigational Site
Tel Aviv
64239
Israel
GSK Investigational Site
Tel Litwinsky
52621
Israel
GSK Investigational Site
Rome
Lazio
00168
Italy
GSK Investigational Site
Brescia
Lombardy
25123
Italy
GSK Investigational Site
Milan
Lombardy
20141
Italy
GSK Investigational Site
Catania
Sicily
95126
Italy
GSK Investigational Site
Milan
20133
Italy
GSK Investigational Site
Bergen
5021
Norway
GSK Investigational Site
Oslo
0379
Norway
GSK Investigational Site
Bialystok
15-207
Poland
GSK Investigational Site
Gdansk
80-219
Poland
GSK Investigational Site
Lodz
94-029
Poland
GSK Investigational Site
Poznan
60-569
Poland
GSK Investigational Site
Oviedo
Principality of Asturias
33011
Spain
GSK Investigational Site
Barcelona
08907
Spain
GSK Investigational Site
Barcelona
8035
Spain
GSK Investigational Site
Madrid
28033
Spain
GSK Investigational Site
Madrid
28040
Spain
GSK Investigational Site
Madrid
28046
Spain
GSK Investigational Site
Palma de Mallorca
07198
Spain
GSK Investigational Site
Linköping
SE-581 85
Sweden
GSK Investigational Site
Lund
SE-221 85
Sweden
GSK Investigational Site
Stockholm
SE-171 76
Sweden
GSK Investigational Site
Nottingham
Nottinghamshire
NG5 1PB
United Kingdom
GSK Investigational Site
Yeovil
Somerset
BA21 4AT
United Kingdom
GSK Investigational Site
Birmingham
West Midlands
B18 7QH
United Kingdom
GSK Investigational Site
Bebington, Wirral
CH63 4JY
United Kingdom
GSK Investigational Site
London
NW1 2PG
United Kingdom
GSK Investigational Site
London
SE1 9RT
United Kingdom
GSK Investigational Site
London
SW3 6JJ
United Kingdom
GSK Investigational Site
London
SW36JJ
United Kingdom
GSK Investigational Site
Maidstone
ME16 9QQ
United Kingdom
GSK Investigational Site
Rhyl
LL18 5UJ
United Kingdom
GSK Investigational Site
Taunton
TA1 5DA
United Kingdom
Background
Mirza MR, Lindahl G, Mahner S, Redondo A, Fabbro M, Rimel BJ, Herrstedt J, Oza AM, Canzler U, Berek JS, Gonzalez-Martin A, Follana P, Lord R, Azodi M, Estenson K, Wang Z, Li Y, Gupta D, Matulonis U, Feng B. Ad hoc Analysis of the Phase III ENGOT-OV16/NOVA Study: Niraparib Efficacy in Germline BRCA Wild-type Recurrent Ovarian Cancer with Homologous Recombination Repair Defects. Cancer Res Commun. 2022 Nov 15;2(11):1436-1444. doi: 10.1158/2767-9764.CRC-22-0240. eCollection 2022 Nov.
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
Mirza MR, Benigno B, Dorum A, Mahner S, Bessette P, Barcelo IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herraez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.
Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.
Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
FG002
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
FG003
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
FG004
FE Sub-study: Fasted/Fed
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.
FG005
FE Sub-study: Fed/Fasted
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.
FG006
QTc Sub-study: Niraparib
Participants received Niraparib 300 mg once daily orally.
FG007
gBRCA Niraparib (Post-study Unblinding [PSU])
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
FG008
gBRCA Placebo (PSU)
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
FG009
Non-gBRCA Niraparib (PSU)
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
FG010
Non-gBRCA Placebo (PSU)
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
FG000138 subjects
FG00165 subjects
FG002234 subjects
FG003116 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG000138 subjects
FG00165 subjects
FG002234 subjects
FG003116 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Ongoing at the time of analysis
FG00022 subjects
FG0018 subjects
FG00231 subjects
FG00313 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG00020 subjects
FG00111 subjects
FG00229 subjects
FG00314 subjects
FG004
Lost to Follow-up
FG0007 subjects
FG0012 subjects
FG0025 subjects
FG0031 subjects
FG004
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Subject unblinded by sponsor
FG00012 subjects
FG00112 subjects
FG00215 subjects
FG00314 subjects
FG004
Death
FG00072 subjects
FG00129 subjects
FG002146 subjects
FG00368 subjects
FG004
Other reasons
FG0005 subjects
FG0013 subjects
FG0028 subjects
FG0034 subjects
FG004
FE Sub-study, Period1 (Day1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0059 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
FE Sub-study, Washout 1 (Up to Day 7)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Transferred to Other Arm/Group
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
FE Sub-study, Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0047 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
QTcSub-study(Upto 5 Year,10 Month,22day)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00626 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Main Study PSU (Up to 8months, 26days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00722 subjects
FG0088 subjects
FG00931 subjects
FG01013 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Subject Unblinded by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
gBRCA Niraparib
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.
BG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
BG002
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
BG003
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
BG004
FE Sub-study: Fasted/Fed
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.
BG005
FE Sub-study: Fed/Fasted
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.
BG006
QTc Sub-study: Niraparib
Participants received Niraparib 300 mg once daily orally.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000138
BG00165
BG002234
BG003116
BG0048
BG0059
BG00626
BG007596
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000138
BG00165
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
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.
Intent-to-treat population was defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Posted
Median
95% Confidence Interval
months
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
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00021(12.9 to NA)Upper limit of confidence interval (CI) was not estimable as upper limits of CI for survivor function were above 0.5 (SAS PROC LIFETEST).
OG0015.5(3.8 to 7.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
<0.0001
Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.
Hazard Ratio (HR)
0.27
2-Sided
95
0.173
0.410
Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
Superiority
Primary
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Median
95% Confidence Interval
months
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
ID
Title
Description
OG000
Non-gBRCAmut HRD+ Niraparib
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
OG001
Non-gBRCAmut HRD+ Placebo
Primary
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
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.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
Non-gBRCA Niraparib
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
OG001
Non-gBRCA Placebo
Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Secondary
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
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.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000
Secondary
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
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
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000
Secondary
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
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
Intent-to-treat Population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000
Secondary
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
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
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000
Secondary
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
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.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
Secondary
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
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.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
Secondary
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Overall survival was defined as the date of randomization to the date of death by any cause.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000
Secondary
Overall Survival in Cohort With No Germline BRCA Mutation
Overall survival was defined as the date of randomization to the date of death by any cause.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000
Secondary
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000
Secondary
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Intent-to-treat population
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
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.
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
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.
Intent-to-treat Population.
Posted
Count of Participants
Participants
At Baseline
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
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.
Intent-to-treat Population.
Posted
Count of Participants
Participants
At Baseline
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 2 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 4 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
At Cycle 6 (Each cycle was of 28 days)
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
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").
Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Secondary
Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
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.
Intent-to-treat Population.
Posted
Up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
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.
Intent-to-treat Population.
Posted
Up to 7 years, 7 months and 4 days
ID
Title
Description
OG000
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG001
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000
Secondary
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
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.
Safety Population consisted of all participants who ingested any amount of study drug.
Posted
Count of Participants
Participants
Up to 7 years, 7 months and 6 days
ID
Title
Description
OG000
gBRCA Niraparib
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.
OG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Secondary
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
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
Safety Population.
Posted
Count of Participants
Participants
Up to 8 months, 26 days
ID
Title
Description
OG000
gBRCA Niraparib (PSU)
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.
OG001
gBRCA Placebo (PSU)
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
Secondary
Number of Participants With Non-serious AEs and SAEs in FE Sub-study
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.
Safety Population
Posted
Count of Participants
Participants
Up to 2 years, 3 months and 11 days
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
Secondary
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
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.
Safety Population
Posted
Count of Participants
Participants
Up to 5 years 10 months and 22 days
ID
Title
Description
OG000
QTc Sub-study: Niraparib
Participants received Niraparib 300 mg once daily orally.
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.
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.
Posted
Mean
Standard Deviation
Nanograms*hour per milliliter
Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
OG000
Secondary
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)
Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Nanograms*hour per milliliter
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Nanograms per milliliter
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
OG000
Secondary
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the tmax of niraparib.
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Posted
Median
Full Range
Hour
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
OG000
Secondary
Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Hour
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
ID
Title
Description
OG000
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
OG001
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
Units
Counts
Participants
OG000
Secondary
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
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.
Safety Population
Posted
Count of Participants
Participants
At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
ID
Title
Description
OG000
QTc Sub-study: Niraparib
Participants received Niraparib 300 mg once daily orally.
Units
Counts
Participants
OG000
Time Frame
All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days
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).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
gBRCA Niraparib
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.
72
136
51
136
136
136
EG001
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression
29
65
9
65
62
65
EG002
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
146
231
76
231
231
231
EG003
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
68
114
20
114
110
114
EG004
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
0
16
1
16
4
16
EG005
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
0
16
0
16
6
16
EG006
QTc Sub-study: Niraparib
Participants received Niraparib 300 mg once daily orally.
5
26
12
26
24
26
EG007
gBRCA Niraparib (Post-study Unblinding [PSU])
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
0
22
0
22
0
22
EG008
gBRCA Placebo (PSU)
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
0
8
0
8
0
8
EG009
Non-gBRCA Niraparib (PSU)
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
0
31
0
31
0
31
EG010
Non-gBRCA Placebo (PSU)
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
0
13
0
13
0
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00038 events18 affected136 at risk
EG0010 events0 affected65 at risk
EG00236 events23 affected231 at risk
EG0030 events0 affected114 at risk
EG0040 events0 affected16 at risk
EG0050 events0 affected16 at risk
EG0069 events3 affected26 at risk
EG0070 events0 affected22 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected31 at risk
EG0100 events0 affected12 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0006 events4 affected136 at risk
EG0010 events0 affected65 at risk
EG00215 events13 affected231 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0023 events2 affected231 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected136 at risk
EG0010 events0 affected65 at risk
EG0027 events6 affected231 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events1 affected231 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0023 events3 affected231 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected136 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Acute erythroid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0024 events3 affected231 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Troponin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Breast disorder
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Malignant gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events1 affected231 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Empyema
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Undifferentiated sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Ovarian cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events1 affected231 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0022 events2 affected231 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Anaphylactoid reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Thrombosis in device
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected231 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Product use complaint
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG000259 events74 affected136 at risk
EG0015 events5 affected65 at risk
EG002328 events111 affected231 at risk
EG00311 events7 affected114 at risk
EG0041 events1 affected16 at risk
EG0050 events0 affected16 at risk
EG00623 events12 affected26 at risk
EG0070 events0 affected22 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected31 at risk
EG0100 events0 affected13 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00077 events24 affected136 at risk
EG0017 events3 affected65 at risk
EG002128 events42 affected231 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG000226 events13 affected136 at risk
EG0013 events2 affected65 at risk
EG002256 events93 affected231 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00050 events34 affected136 at risk
EG00124 events17 affected65 at risk
EG00293 events63 affected231 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG000105 events56 affected136 at risk
EG00114 events12 affected65 at risk
EG002163 events96 affected231 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00071 events40 affected136 at risk
EG00128 events15 affected65 at risk
EG00276 events44 affected231 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected136 at risk
EG0013 events3 affected65 at risk
EG00217 events12 affected231 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG000205 events106 affected136 at risk
EG00146 events23 affected65 at risk
EG002304 events168 affected231 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected136 at risk
EG0014 events4 affected65 at risk
EG00218 events11 affected231 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00096 events57 affected136 at risk
EG00113 events10 affected65 at risk
EG002126 events74 affected231 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG000134 events66 affected136 at risk
EG00137 events19 affected65 at risk
EG002189 events110 affected231 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG00015 events12 affected136 at risk
EG0013 events2 affected65 at risk
EG00223 events15 affected231 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00025 events20 affected136 at risk
EG00111 events6 affected65 at risk
EG00240 events26 affected231 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00029 events11 affected136 at risk
EG0014 events3 affected65 at risk
EG00232 events15 affected231 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00017 events7 affected136 at risk
EG0013 events3 affected65 at risk
EG00248 events20 affected231 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00064 events23 affected136 at risk
EG0015 events3 affected65 at risk
EG00279 events31 affected231 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00085 events34 affected136 at risk
EG0011 events1 affected65 at risk
EG002132 events45 affected231 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00042 events20 affected136 at risk
EG00114 events5 affected65 at risk
EG00264 events22 affected231 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00049 events30 affected136 at risk
EG00112 events9 affected65 at risk
EG00294 events67 affected231 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0008 events7 affected136 at risk
EG00110 events5 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00014 events11 affected136 at risk
EG00110 events5 affected65 at risk
EG00226 events15 affected231 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00040 events15 affected136 at risk
EG00118 events8 affected65 at risk
EG00228 events18 affected231 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00039 events26 affected136 at risk
EG00114 events7 affected65 at risk
EG00253 events43 affected231 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00076 events52 affected136 at risk
EG00112 events7 affected65 at risk
EG00297 events52 affected231 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00017 events13 affected136 at risk
EG0014 events4 affected65 at risk
EG00219 events14 affected231 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00036 events26 affected136 at risk
EG0017 events6 affected65 at risk
EG00288 events67 affected231 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00036 events26 affected136 at risk
EG0014 events2 affected65 at risk
EG00260 events42 affected231 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00034 events23 affected136 at risk
EG0014 events3 affected65 at risk
EG00262 events49 affected231 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00016 events14 affected136 at risk
EG0011 events1 affected65 at risk
EG00220 events16 affected231 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG000123 events38 affected136 at risk
EG0016 events5 affected65 at risk
EG002207 events46 affected231 at risk
EG003
Catheter site pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00013 events12 affected136 at risk
EG0011 events1 affected65 at risk
EG00218 events14 affected231 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00026 events17 affected136 at risk
EG00112 events9 affected65 at risk
EG00236 events24 affected231 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events4 affected136 at risk
EG0017 events6 affected65 at risk
EG00229 events23 affected231 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00037 events23 affected136 at risk
EG00111 events10 affected65 at risk
EG00225 events22 affected231 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00038 events19 affected136 at risk
EG0015 events2 affected6 at risk
EG00227 events19 affected231 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG00075 events27 affected136 at risk
EG0013 events3 affected65 at risk
EG00281 events36 affected231 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG00017 events11 affected136 at risk
EG0015 events4 affected65 at risk
EG00223 events16 affected231 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG00011 events8 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected136 at risk
EG0011 events1 affected65 at risk
EG00223 events19 affected231 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00038 events11 affected136 at risk
EG0016 events4 affected65 at risk
EG00252 events17 affected231 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00031 events11 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0007 events7 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00033 events21 affected136 at risk
EG0017 events4 affected65 at risk
EG00240 events29 affected231 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00018 events15 affected136 at risk
EG0015 events3 affected65 at risk
EG00218 events14 affected231 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00013 events10 affected136 at risk
EG0011 events1 affected65 at risk
EG00219 events15 affected231 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected136 at risk
EG0014 events4 affected65 at risk
EG00219 events15 affected231 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00015 events9 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00010 events7 affected136 at risk
EG0010 events0 affected65 at risk
EG00221 events13 affected231 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00015 events7 affected136 at risk
EG0010 events0 affected65 at risk
EG00227 events15 affected231 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG00219 events13 affected231 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00044 events29 affected136 at risk
EG00111 events10 affected65 at risk
EG00240 events27 affected231 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00040 events29 affected136 at risk
EG0019 events9 affected65 at risk
EG00238 events33 affected231 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00027 events19 affected136 at risk
EG0014 events4 affected65 at risk
EG00219 events16 affected231 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00024 events16 affected136 at risk
EG0012 events2 affected65 at risk
EG00215 events14 affected231 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00018 events15 affected136 at risk
EG0017 events6 affected65 at risk
EG00224 events21 affected231 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00014 events11 affected136 at risk
EG0012 events2 affected65 at risk
EG00223 events12 affected231 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG0029 events8 affected231 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00017 events15 affected136 at risk
EG0016 events6 affected65 at risk
EG00221 events20 affected231 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00013 events12 affected136 at risk
EG0013 events3 affected65 at risk
EG0025 events5 affected231 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00013 events11 affected136 at risk
EG0010 events0 affected65 at risk
EG00237 events25 affected231 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00010 events9 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00019 events11 affected136 at risk
EG0012 events2 affected65 at risk
EG00221 events16 affected231 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected136 at risk
EG0010 events0 affected65 at risk
EG00215 events12 affected231 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG00011 events10 affected136 at risk
EG0013 events3 affected65 at risk
EG00243 events24 affected231 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00027 events12 affected136 at risk
EG00111 events7 affected65 at risk
EG00227 events21 affected231 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00014 events9 affected136 at risk
EG0013 events2 affected65 at risk
EG00221 events14 affected231 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG00012 events10 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG00010 events7 affected136 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG00019 events14 affected136 at risk
EG0011 events1 affected65 at risk
EG00235 events27 affected231 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG00013 events11 affected136 at risk
EG0011 events1 affected65 at risk
EG00220 events14 affected231 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG00011 events7 affected136 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG00230 events18 affected231 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 events7 affected136 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected231 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected136 at risk
EG0010 events0 affected65 at risk
EG00225 events22 affected231 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C545685
niraparib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
8 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
7 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
7 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG00626 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Other Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00617 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00722 subjects
FG0088 subjects
FG00931 subjects
FG01013 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00715 subjects
FG0088 subjects
FG00918 subjects
FG01012 subjects
Subject Moved to Rollover Study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0076 subjects
FG0080 subjects
FG0099 subjects
FG0100 subjects
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0093 subjects
FG0101 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 64 years
BG000110
BG00149
BG002130
BG00369
BG0045
BG0055
BG00616
BG007384
>=65 years
BG00028
BG00116
BG002104
BG00347
BG0043
BG0054
BG00610
BG007212
234
BG003116
BG0048
BG0059
BG00626
BG007596
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
0
BG0030
BG0040
BG0050
BG0061
BG0072
Asian
BG0002
BG0013
BG00210
BG0034
BG0040
BG0050
BG0061
BG00720
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0071
Black or African American
BG0001
BG0011
BG0024
BG0031
BG0041
BG0050
BG0063
BG00711
White
BG000123
BG00155
BG002201
BG003101
BG0046
BG0059
BG00621
BG007516
Unknown or Not Reported
BG00011
BG0016
BG00219
BG00310
BG0040
BG0050
BG0060
BG00746
Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
Units
Counts
Participants
OG000106
OG00156
Title
Denominators
Categories
Title
Measurements
OG00012.9(8.1 to 15.9)
OG0013.8(3.5 to 5.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
<0.0001
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
Hazard Ratio (HR)
0.38
2-Sided
95
0.243
0.586
Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
Superiority
Units
Counts
Participants
OG000234
OG001116
Title
Denominators
Categories
Title
Measurements
OG0009.3(7.2 to 11.2)
OG0013.9(3.7 to 5.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
<0.0001
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.
Hazard Ratio (HR)
0.45
2-Sided
95
0.338
0.607
Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
Superiority
138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00019.1(14.6 to 21.9)
OG0018.6(6.9 to 12.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0005
Two-sided p-value
Hazard Ratio (HR)
0.57
2-Sided
95
0.412
0.783
Superiority
234
OG001116
Title
Denominators
Categories
Title
Measurements
OG00012.4(10.9 to 14.5)
OG0017.4(5.9 to 8.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
Two-sided P-value.
Hazard Ratio (HR)
0.58
2-Sided
95
0.454
0.740
Superiority
138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00020.0(16.2 to 23.3)
OG0019.4(7.9 to 10.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
Two-sided P-value.
Hazard Ratio (HR)
0.39
2-Sided
95
0.268
0.561
Superiority
234
OG001116
Title
Denominators
Categories
Title
Measurements
OG00013.4(11.3 to 14.8)
OG0018.7(6.9 to 10.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
Two-sided P-value.
Hazard Ratio (HR)
0.56
2-Sided
95
0.428
0.727
Superiority
OG000138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00029.9(24.8 to 33.4)
OG00122.7(19.5 to 25.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0302
Two-sided P-value.
Hazard Ratio (HR)
0.70
2-Sided
95
0.500
0.968
Superiority
OG000234
OG001116
Title
Denominators
Categories
Title
Measurements
OG00019.5(17.1 to 22.3)
OG00116.1(13.6 to 22.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0748
Two-sided P-value.
Hazard Ratio (HR)
0.80
2-Sided
95
0.627
1.022
Superiority
138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00040.9(34.9 to 52.9)
OG00138.1(27.6 to 47.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.3580
Two-sided P-value.
Hazard Ratio (HR)
0.85
2-Sided
95
0.606
1.198
Superiority
234
OG001116
Title
Denominators
Categories
Title
Measurements
OG00031.0(27.8 to 35.6)
OG00134.8(27.9 to 41.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.6868
Two-sided P-value.
Hazard Ratio (HR)
1.06
2-Sided
95
0.813
1.369
Superiority
138
OG00165
Title
Denominators
Categories
Title
Measurements
OG00029.7(23.3 to 33.4)
OG00119.6(14.4 to 25.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0061
Two-sided P-value.
Hazard Ratio (HR)
0.63
2-Sided
95
0.451
0.878
Superiority
234
OG001116
Title
Denominators
Categories
Title
Measurements
OG00020.3(18.0 to 23.4)
OG00116.7(14.9 to 21.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.1674
Two-sided P-value.
Hazard Ratio (HR)
0.84
2-Sided
95
0.654
1.077
Superiority
Units
Counts
Participants
OG000114
OG00155
Title
Denominators
Categories
Title
Measurements
OG000-0.8± 4.58
OG001-0.3± 3.19
Units
Counts
Participants
OG000109
OG00143
Title
Denominators
Categories
Title
Measurements
OG000-0.1± 4.07
OG001-0.3± 3.88
Units
Counts
Participants
OG00095
OG00136
Title
Denominators
Categories
Title
Measurements
OG0000.5± 3.77
OG001-0.5± 4.27
Units
Counts
Participants
OG00080
OG00137
Title
Denominators
Categories
Title
Measurements
OG000-0.751± 4.4342
OG001-1.324± 4.5034
Units
Counts
Participants
OG000181
OG00197
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 3.79
OG001-0.3± 2.84
Units
Counts
Participants
OG000150
OG00177
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 4.16
OG001-0.9± 4.23
Units
Counts
Participants
OG000124
OG00150
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 3.76
OG001-0.9± 3.43
Units
Counts
Participants
OG000146
OG00182
Title
Denominators
Categories
Title
Measurements
OG000-2.595± 5.5700
OG001-1.801± 4.0290
Units
Counts
Participants
OG000118
OG00159
Title
Denominators
Categories
Title
Measurements
OG000-0.008± 0.1092
OG001-0.008± 0.1354
Units
Counts
Participants
OG000113
OG00144
Title
Denominators
Categories
Title
Measurements
OG000-0.010± 0.1225
OG001-0.035± 0.1156
Units
Counts
Participants
OG00099
OG00136
Title
Denominators
Categories
Title
Measurements
OG0000.002± 0.1116
OG001-0.004± 0.1463
Units
Counts
Participants
OG00081
OG00138
Title
Denominators
Categories
Title
Measurements
OG000-0.041± 0.1192
OG001-0.013± 0.1580
Units
Counts
Participants
OG000185
OG00196
Title
Denominators
Categories
Title
Measurements
OG000-0.007± 0.1013
OG001-0.011± 0.1015
Units
Counts
Participants
OG000155
OG00180
Title
Denominators
Categories
Title
Measurements
OG000-0.004± 0.1077
OG001-0.014± 0.0870
Units
Counts
Participants
OG000127
OG00150
Title
Denominators
Categories
Title
Measurements
OG0000.005± 0.1097
OG001-0.011± 0.0949
Units
Counts
Participants
OG000149
OG00184
Title
Denominators
Categories
Title
Measurements
OG000-0.047± 0.1355
OG001-0.050± 0.1351
Units
Counts
Participants
OG000138
OG00165
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00047
OG00126
Feet, 1-A little bit
Title
Measurements
OG00032
OG00112
Feet, 2-Somewhat
Title
Measurements
OG00024
OG0019
Feet, 3-Quite a bit
Title
Measurements
OG00021
OG00110
Feet, 4-Very much
Title
Measurements
OG0009
OG0016
Hands, 0-Not at all
Title
Measurements
OG00080
OG00137
Hands, 1-A little bit
Title
Measurements
OG00028
OG00113
Hands, 2-Somewhat
Title
Measurements
OG0008
OG0016
Hands, 3-Quite a bit
Title
Measurements
OG00014
OG0015
Hands, 4-Very much
Title
Measurements
OG0003
OG0012
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.7969
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.8794
Superiority
Units
Counts
Participants
OG000132
OG00164
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00048
OG00125
Feet, 1-A little bit
Title
Measurements
OG00022
OG0015
Feet, 2-Somewhat
Title
Measurements
OG00017
OG00115
Feet, 3-Quite a bit
Title
Measurements
OG00020
OG00110
Feet, 4-Very much
Title
Measurements
OG0008
OG0013
Hands, 0-Not at all
Title
Measurements
OG00073
OG00131
Hands, 1-A little bit
Title
Measurements
OG00019
OG00116
Hands, 2-Somewhat
Title
Measurements
OG00013
OG0016
Hands, 3-Quite a bit
Title
Measurements
OG0007
OG0012
Hands, 4-Very much
Title
Measurements
OG0003
OG0012
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.2399
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.4584
Superiority
Units
Counts
Participants
OG000120
OG00154
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00047
OG00120
Feet, 1-A little bit
Title
Measurements
OG00022
OG0016
Feet, 2-Somewhat
Title
Measurements
OG00020
OG0017
Feet, 3-Quite a bit
Title
Measurements
OG00015
OG0018
Feet, 4-Very much
Title
Measurements
OG0006
OG0012
Hands, 0-Not at all
Title
Measurements
OG00070
OG00129
Hands, 1-A little bit
Title
Measurements
OG00018
OG0016
Hands, 2-Somewhat
Title
Measurements
OG00016
OG0013
Hands, 3-Quite a bit
Title
Measurements
OG0004
OG0014
Hands, 4-Very much
Title
Measurements
OG0002
OG0011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.8566
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.4705
Superiority
Units
Counts
Participants
OG000105
OG00141
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00044
OG00117
Feet, 1-A little bit
Title
Measurements
OG00017
OG0015
Feet, 2-Somewhat
Title
Measurements
OG00013
OG0017
Feet, 3-Quite a bit
Title
Measurements
OG00015
OG0015
Feet, 4-Very much
Title
Measurements
OG0009
OG0012
Hands, 0-Not at all
Title
Measurements
OG00054
OG00121
Hands, 1-A little bit
Title
Measurements
OG00025
OG0018
Hands, 2-Somewhat
Title
Measurements
OG00010
OG0014
Hands, 3-Quite a bit
Title
Measurements
OG0006
OG0012
Hands, 4-Very much
Title
Measurements
OG0002
OG0011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.8521
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.9923
Superiority
Units
Counts
Participants
OG000104
OG00149
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00031
OG00115
Feet, 1-A little bit
Title
Measurements
OG00020
OG0019
Feet, 2-Somewhat
Title
Measurements
OG0007
OG0013
Feet, 3-Quite a bit
Title
Measurements
OG00015
OG0017
Feet, 4-Very much
Title
Measurements
OG0007
OG0013
Hands, 0-Not at all
Title
Measurements
OG00044
OG00126
Hands, 1-A little bit
Title
Measurements
OG00018
OG0014
Hands, 2-Somewhat
Title
Measurements
OG0008
OG0013
Hands, 3-Quite a bit
Title
Measurements
OG0007
OG0014
Hands, 4-Very much
Title
Measurements
OG0003
OG0010
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.9997
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.3518
Superiority
Units
Counts
Participants
OG000234
OG001116
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00071
OG00140
Feet, 1-A little bit
Title
Measurements
OG00058
OG00126
Feet, 2-Somewhat
Title
Measurements
OG00037
OG00116
Feet, 3-Quite a bit
Title
Measurements
OG00043
OG00121
Feet, 4-Very much
Title
Measurements
OG00018
OG0019
Hands, 0-Not at all
Title
Measurements
OG000120
OG00148
Hands, 1-A little bit
Title
Measurements
OG00056
OG00137
Hands, 2-Somewhat
Title
Measurements
OG00028
OG00112
Hands, 3-Quite a bit
Title
Measurements
OG00015
OG00111
Hands, 4-Very much
Title
Measurements
OG0008
OG0012
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.9367
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.2502
Superiority
Units
Counts
Participants
OG000212
OG001113
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00069
OG00132
Feet, 1-A little bit
Title
Measurements
OG00039
OG00117
Feet, 2-Somewhat
Title
Measurements
OG00030
OG00112
Feet, 3-Quite a bit
Title
Measurements
OG00034
OG00118
Feet, 4-Very much
Title
Measurements
OG0009
OG0018
Hands, 0-Not at all
Title
Measurements
OG000100
OG00144
Hands, 1-A little bit
Title
Measurements
OG00038
OG00124
Hands, 2-Somewhat
Title
Measurements
OG00020
OG00119
Hands, 3-Quite a bit
Title
Measurements
OG00017
OG0015
Hands, 4-Very much
Title
Measurements
OG0004
OG0013
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.5037
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.1640
Superiority
Units
Counts
Participants
OG000181
OG00195
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00054
OG00131
Feet, 1-A little bit
Title
Measurements
OG00037
OG00116
Feet, 2-Somewhat
Title
Measurements
OG00034
OG00117
Feet, 3-Quite a bit
Title
Measurements
OG00020
OG00111
Feet, 4-Very much
Title
Measurements
OG0009
OG0015
Hands, 0-Not at all
Title
Measurements
OG00089
OG00143
Hands, 1-A little bit
Title
Measurements
OG00029
OG00121
Hands, 2-Somewhat
Title
Measurements
OG00014
OG00110
Hands, 3-Quite a bit
Title
Measurements
OG00014
OG0013
Hands, 4-Very much
Title
Measurements
OG0006
OG0011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.9599
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.2470
Superiority
Units
Counts
Participants
OG000144
OG00156
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00043
OG00116
Feet, 1-A little bit
Title
Measurements
OG00029
OG00110
Feet, 2-Somewhat
Title
Measurements
OG00030
OG00111
Feet, 3-Quite a bit
Title
Measurements
OG00018
OG0019
Feet, 4-Very much
Title
Measurements
OG0005
OG0015
Hands, 0-Not at all
Title
Measurements
OG00068
OG00129
Hands, 1-A little bit
Title
Measurements
OG00030
OG00110
Hands, 2-Somewhat
Title
Measurements
OG00013
OG0016
Hands, 3-Quite a bit
Title
Measurements
OG0009
OG0015
Hands, 4-Very much
Title
Measurements
OG0003
OG0010
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet
0.5921
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.7459
Superiority
Units
Counts
Participants
OG000185
OG001105
Title
Denominators
Categories
Feet, 0-Not at all
Title
Measurements
OG00057
OG00132
Feet, 1-A little bit
Title
Measurements
OG00045
OG00112
Feet, 2-Somewhat
Title
Measurements
OG00023
OG00116
Feet, 3-Quite a bit
Title
Measurements
OG00019
OG00116
Feet, 4-Very much
Title
Measurements
OG0005
OG0018
Hands, 0-Not at all
Title
Measurements
OG00088
OG00148
Hands, 1-A little bit
Title
Measurements
OG00035
OG00115
Hands, 2-Somewhat
Title
Measurements
OG00013
OG0019
Hands, 3-Quite a bit
Title
Measurements
OG0007
OG00110
Hands, 4-Very much
Title
Measurements
OG0003
OG0011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-squared test
0.0259
Superiority
OG000
OG001
Pearson's Chi-squared test
Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands
0.2798
Superiority
0
OG0010
0
OG0010
OG002
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
OG003
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
Units
Counts
Participants
OG000136
OG00165
OG002231
OG003114
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG000136
OG00162
OG002231
OG003110
SAEs
Title
Measurements
OG00051
OG0019
OG00276
OG003
OG002
Non-gBRCA Niraparib (PSU)
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
OG003
Non-gBRCA Placebo (PSU)
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