Trial Outcomes & Findings for Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule (NCT NCT03329001)
NCT ID: NCT03329001
Last Updated: 2024-07-25
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
236 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Results posted on
2024-07-25
Participant Flow
This was a 3-stage, single cross-over study. The study had a pharmacokinetic (PK) phase consisting of stages 1, 2, and 3 and an Extension Phase. The Extension Phase based on Investigator and Sponsor's decision provided qualifying participants continued access to niraparib therapy.
A total of 236 participants were enrolled. The Safety Population comprised all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study.
Participant milestones
| Measure |
Stage 1: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety follow-up \[f/u\]) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 1: Niraparib Capsule/Tablet
Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Capsule/Tablet
Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fasted/Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fed/Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
Extension Phase: Niraparib Capsule
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: PK Phase- Period 1 (Day 1)
STARTED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: PK Phase- Period 1 (Day 1)
COMPLETED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: PK Phase- Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase Washout1(W)(Up to Day 7)
STARTED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase Washout1(W)(Up to Day 7)
COMPLETED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase Washout1(W)(Up to Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: PK Phase- Period 2 (Day 1)
STARTED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: PK Phase- Period 2 (Day 1)
COMPLETED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: PK Phase- Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase W2 (Up to Day 7)
STARTED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase W2 (Up to Day 7)
COMPLETED
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage1:PK Phase W2 (Up to Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-Period 1 (Day 1)
STARTED
|
0
|
0
|
90
|
89
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-Period 1 (Day 1)
Treatment Received
|
0
|
0
|
85
|
83
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-Period 1 (Day 1)
COMPLETED
|
0
|
0
|
85
|
83
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
5
|
6
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
STARTED
|
0
|
0
|
85
|
83
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
COMPLETED
|
0
|
0
|
69
|
71
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
NOT COMPLETED
|
0
|
0
|
16
|
12
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase- Period 2 (Day 15)
STARTED
|
0
|
0
|
69
|
71
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase- Period 2 (Day 15)
COMPLETED
|
0
|
0
|
69
|
71
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase- Period 2 (Day 15)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
STARTED
|
0
|
0
|
69
|
71
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
COMPLETED
|
0
|
0
|
64
|
66
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
NOT COMPLETED
|
0
|
0
|
5
|
5
|
0
|
0
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
14
|
14
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
12
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
|
Stage 3: PK Phase-W1 (Up to Day 14)
STARTED
|
0
|
0
|
0
|
0
|
11
|
12
|
0
|
0
|
|
Stage 3: PK Phase-W1 (Up to Day 14)
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
12
|
0
|
0
|
|
Stage 3: PK Phase-W1 (Up to Day 14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 3: PK Phase- Period 2 (Day 15)
STARTED
|
0
|
0
|
0
|
0
|
11
|
12
|
0
|
0
|
|
Stage 3: PK Phase- Period 2 (Day 15)
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
11
|
0
|
0
|
|
Stage 3: PK Phase- Period 2 (Day 15)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Stage3:PK Phase W2 (Up to Day 7)
STARTED
|
0
|
0
|
0
|
0
|
10
|
11
|
0
|
0
|
|
Stage3:PK Phase W2 (Up to Day 7)
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
11
|
0
|
0
|
|
Stage3:PK Phase W2 (Up to Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase(Approx 5 Years 5 Months)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
124
|
66
|
|
Extension Phase(Approx 5 Years 5 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
53
|
36
|
|
Extension Phase(Approx 5 Years 5 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
30
|
Reasons for withdrawal
| Measure |
Stage 1: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety follow-up \[f/u\]) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 1: Niraparib Capsule/Tablet
Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Capsule/Tablet
Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fasted/Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fed/Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
Extension Phase: Niraparib Capsule
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: PK Phase-Period 1 (Day 1)
Randomized, but did not receive treatment
|
0
|
0
|
5
|
6
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Deemed unevaluable
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Sponsor discontinued the participant
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Sponsor and Investigator decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Participant had incorrectly overdosed and removed from PK phase
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Participant admitted to emergency room for elevated serum creatinine
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Participant unable to complete due to Tornado in site area
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Participant non-compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Vomiting within protocol-specified hours of dose administration
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Disease progression per Investigator Decision
|
0
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Adverse Event
|
0
|
0
|
5
|
2
|
0
|
0
|
0
|
0
|
|
Stage 2: PK Phase-W1 (Up to Day 14)
Death
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Participant had paracentesis
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Participant forgot appointment
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Participant missed PK sampling in Period 1 Day 8
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Deemed unevaluable
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Participant was not in fasted state and therefore was outside of protocol compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Disease progression per Investigator Decision
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Stage2:PK Phase W2 (Up to Day 7)
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
Clinical progression
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Stage 3: PK Phase- Period 1 (Day 1)
Progressive Disease
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 3: PK Phase- Period 2 (Day 15)
Vomiting within protocol-specified hours of dose administration
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Extension Phase(Approx 5 Years 5 Months)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
14
|
|
Extension Phase(Approx 5 Years 5 Months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Extension Phase(Approx 5 Years 5 Months)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
3
|
|
Extension Phase(Approx 5 Years 5 Months)
Other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
13
|
Baseline Characteristics
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
Baseline characteristics by cohort
| Measure |
Stage 1: Niraparib Tablet/Capsule
n=15 Participants
Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety follow-up \[f/u\]) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 1: Niraparib Capsule/Tablet
n=14 Participants
Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Tablet/Capsule
n=85 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 2: Niraparib Capsule/Tablet
n=83 Participants
Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fasted/Fed
n=14 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Stage 3: Niraparib Tablet Fed/Fasted
n=14 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 to <65 years
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
108 Participants
n=3 Participants
|
|
Age, Customized
>=65 to <75 years
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
80 Participants
n=3 Participants
|
|
Age, Customized
>=75 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
37 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
125 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
100 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
171 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: Bioavailability (BA) Evaluable Population included all participants who completed both PK Periods and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover (Baseline concentration \>5 percent (%) of maximum observed plasma concentration \[Cmax\]), in both Periods.
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
|
14900 Hours*nanogram per milliliter
Geometric Coefficient of Variation 43.0
|
16100 Hours*nanogram per milliliter
Geometric Coefficient of Variation 41.3
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
|
16200 Hours*nanogram per milliliter
Geometric Coefficient of Variation 44.5
|
17200 Hours*nanogram per milliliter
Geometric Coefficient of Variation 41.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
|
451 Nanograms per milliliter
Geometric Coefficient of Variation 47.8
|
467 Nanograms per milliliter
Geometric Coefficient of Variation 50.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
|
4.05 Hours
Interval 1.98 to 8.0
|
4.00 Hours
Interval 1.52 to 25.02
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
|
47.3 Hours
Geometric Coefficient of Variation 22.2
|
43.8 Hours
Geometric Coefficient of Variation 23.1
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
|
18.5 Liters per hour
Geometric Coefficient of Variation 44.5
|
17.4 Liters per hour
Geometric Coefficient of Variation 41.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BA Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=23 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=23 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
|
1260 Liters
Geometric Coefficient of Variation 45.4
|
1100 Liters
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: Bioequivalence (BE) Evaluable Population included all participants who completed both the Study Drug and Washout/PK and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover and without events or protocol deviations deemed affect PK, in both Periods. Only those participants with estimable PK parameter data in both periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=107 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=107 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
AUC(0-t) for Niraparib-Stage 2 PK Phase
|
17070 Hours*nanogram per milliliter
Geometric Coefficient of Variation 57.1
|
17730 Hours*nanogram per milliliter
Geometric Coefficient of Variation 54.1
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=98 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=98 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
|
17760 Hours*nanogram per milliliter
Geometric Coefficient of Variation 55.3
|
18470 Hours*nanogram per milliliter
Geometric Coefficient of Variation 53.5
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=108 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=108 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Cmax for Niraparib-Stage 2 PK Phase
|
519.5 Nanograms per milliliter
Geometric Coefficient of Variation 49.5
|
538.4 Nanograms per milliliter
Geometric Coefficient of Variation 49.4
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=108 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=108 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Tmax for Niraparib-Stage 2 PK Phase
|
5.00 Hours
Interval 1.55 to 8.0
|
4.97 Hours
Interval 0.97 to 23.8
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=108 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=108 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
T1/2 for Niraparib-Stage 2 PK Phase
|
47.94 Hours
Geometric Coefficient of Variation 26.4
|
50.17 Hours
Geometric Coefficient of Variation 26.1
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=98 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=98 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
CL/F for Niraparib-Stage 2 PK Phase
|
16.89 Liters per hour
Geometric Coefficient of Variation 55.3
|
16.25 Liters per hour
Geometric Coefficient of Variation 53.5
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=98 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=98 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Vz/F for Niraparib-Stage 2 PK Phase
|
1128 Liters
Geometric Coefficient of Variation 51.1
|
1128 Liters
Geometric Coefficient of Variation 50.9
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: Food Effect (FE) Evaluable Population included all participants who completed both PK periods and had sufficient PK sample collection to accurately estimate PK parameters in both periods. Participants meeting non-evaluability criteria or having significant niraparib carryover (Baseline concentration \>5% of Cmax) were completely excluded from the FE Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=16 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=16 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
AUC(0-t) for Niraparib-Stage 3 PK Phase
|
20100 Hours*nanogram per milliliter
Geometric Coefficient of Variation 63.9
|
25990 Hours*nanogram per milliliter
Geometric Coefficient of Variation 52.4
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=18 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=18 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
|
23600 Hours*nanogram per milliliter
Geometric Coefficient of Variation 78.5
|
29770 Hours*nanogram per milliliter
Geometric Coefficient of Variation 65.2
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population.
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=19 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=19 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Cmax for Niraparib-Stage 3 PK Phase
|
704.1 Nanograms per milliliter
Geometric Coefficient of Variation 57.0
|
774.6 Nanograms per milliliter
Geometric Coefficient of Variation 47.2
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population.
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=19 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=19 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Tmax for Niraparib-Stage 3 PK Phase
|
4.88 Hours
Interval 2.97 to 7.1
|
5.97 Hours
Interval 0.98 to 11.1
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population.
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=19 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=19 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
T1/2 for Niraparib-Stage 3 PK Phase
|
46.39 Hours
Geometric Coefficient of Variation 20.5
|
46.08 Hours
Geometric Coefficient of Variation 22.4
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=18 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=18 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
CL/F for Niraparib-Stage 3 PK Phase
|
12.71 Liters per hour
Geometric Coefficient of Variation 78.5
|
10.08 Liters per hour
Geometric Coefficient of Variation 65.2
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=18 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=18 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Vz/F for Niraparib-Stage 3 PK Phase
|
833.8 Liters
Geometric Coefficient of Variation 83.5
|
651.4 Liters
Geometric Coefficient of Variation 54.3
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment periodPopulation: FE Evaluable Population.
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=19 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=19 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
|
0.00 Hours
Interval 0.0 to 0.97
|
0.00 Hours
Interval 0.0 to 2.93
|
SECONDARY outcome
Timeframe: Up to 16 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 1 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=29 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=29 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
TEAE
|
9 Participants
|
12 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
Serious TEAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 1 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=29 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=29 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 2 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=156 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=152 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
TEAE
|
86 Participants
|
73 Participants
|
|
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
Serious TEAE
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 24 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 2 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=156 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=152 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 3 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=26 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=25 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
TEAE
|
8 Participants
|
12 Participants
|
|
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
Serious TEAE
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population comprised of all participants who received any amount of niraparib during the Stage 3 PK Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=26 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=25 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 5 years 5 monthsPopulation: Safety Population comprised of all participants who received any amount of niraparib in the Open-Label Extension Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=124 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=66 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
TEAEs
|
120 Participants
|
65 Participants
|
|
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
Serious TEAEs
|
40 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 5 years 5 monthsPopulation: Safety Population comprised of all participants who received any amount of niraparib in the Open-Label Extension Phase of the study.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Outcome measures
| Measure |
Stage 1: Niraparib Tablet
n=124 Participants
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=66 Participants
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
|---|---|---|
|
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
|
8 Participants
|
9 Participants
|
Adverse Events
Stage 1: Niraparib Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1: Niraparib Capsule
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 2: Niraparib Tablet
Serious events: 10 serious events
Other events: 49 other events
Deaths: 2 deaths
Stage 2: Niraparib Capsule
Serious events: 10 serious events
Other events: 37 other events
Deaths: 5 deaths
Stage 3: Niraparib Tablet Fasted
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Stage 3: Niraparib Tablet Fed
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Extension Phase: Niraparib Tablet
Serious events: 40 serious events
Other events: 113 other events
Deaths: 15 deaths
Extension Phase: Niraparib Capsule
Serious events: 20 serious events
Other events: 64 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Stage 1: Niraparib Tablet
n=29 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=29 participants at risk
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 2: Niraparib Tablet
n=156 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
|
Stage 2: Niraparib Capsule
n=152 participants at risk
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
|
Stage 3: Niraparib Tablet Fasted
n=26 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
|
Stage 3: Niraparib Tablet Fed
n=25 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
|
Extension Phase: Niraparib Tablet
n=124 participants at risk
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
Extension Phase: Niraparib Capsule
n=66 participants at risk
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.3%
2/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.8%
1/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
2.4%
3/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.3%
2/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
2/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.3%
2/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.8%
1/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.2%
4/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
2.4%
3/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.8%
9/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.3%
8/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.0%
2/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.5%
3/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.64%
1/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.66%
1/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.8%
1/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.0%
1/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.8%
1/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Infection
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.0%
1/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.8%
1/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.5%
3/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
2.4%
3/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Asthenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Chest pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Death
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Pyrexia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.5%
1/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
Other adverse events
| Measure |
Stage 1: Niraparib Tablet
n=29 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 1: Niraparib Capsule
n=29 participants at risk
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
|
Stage 2: Niraparib Tablet
n=156 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
|
Stage 2: Niraparib Capsule
n=152 participants at risk
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
|
Stage 3: Niraparib Tablet Fasted
n=26 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
|
Stage 3: Niraparib Tablet Fed
n=25 participants at risk
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
|
Extension Phase: Niraparib Tablet
n=124 participants at risk
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
Extension Phase: Niraparib Capsule
n=66 participants at risk
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
17.2%
5/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
10.9%
17/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.6%
13/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
2/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.0%
2/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
37.9%
47/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
42.4%
28/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.9%
2/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.4%
10/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.3%
8/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
2/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.0%
1/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
31.5%
39/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
28.8%
19/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Fatigue
|
3.4%
1/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.9%
2/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
12/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.3%
8/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
27.4%
34/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
33.3%
22/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
10.3%
16/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.6%
10/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
2/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
25.0%
31/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
16.7%
11/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.8%
9/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.3%
8/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.0%
2/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
28.2%
35/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
30.3%
20/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.0%
2/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.7%
12/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
18.2%
12/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.7%
2/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
15.3%
19/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
12.1%
8/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.0%
2/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.6%
7/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.7%
12/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.1%
6/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.8%
6/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.1%
4/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
14.5%
18/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
12.1%
8/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.2%
4/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
12.9%
16/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.1%
4/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Weight decreased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.1%
10/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
10.6%
7/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
10.5%
13/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.5%
3/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
4.8%
6/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
1.6%
2/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.1%
4/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
General disorders
Asthenia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
22.6%
28/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.1%
6/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
12.9%
16/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.1%
6/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
13.7%
17/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.1%
6/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.9%
11/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
10.5%
13/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.1%
4/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
2.4%
3/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
18.2%
12/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
2.4%
3/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
6.1%
4/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
8.9%
11/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
12.1%
8/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.3%
9/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
9.1%
6/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
5.6%
7/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
3.0%
2/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/29 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/156 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/152 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/26 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.00%
0/25 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
0.81%
1/124 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
7.6%
5/66 • All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER