Trial Outcomes & Findings for Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients (NCT NCT03359850)
NCT ID: NCT03359850
Last Updated: 2021-05-28
Results Overview
Blood samples were collected at indicated time points to evaluate AUC (last) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Results posted on
2021-05-28
Participant Flow
This study evaluated pharmacokinetics and safety of niraparib in participants with advanced solid tumors and with either normal hepatic function or moderate hepatic impairment.
This is a 2 period study including pharmacokinetic (PK) phase and extension (Ext.) phase. A total of 17 participants were enrolled in the study and received study treatment, niraparib.
Participant milestones
| Measure |
Participants With Normal Hepatic Function
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
PK Phase (Up to Day 8)
STARTED
|
9
|
8
|
|
PK Phase (Up to Day 8)
COMPLETED
|
8
|
7
|
|
PK Phase (Up to Day 8)
NOT COMPLETED
|
1
|
1
|
|
Extension Phase (Up to 28 Months)
STARTED
|
8
|
7
|
|
Extension Phase (Up to 28 Months)
COMPLETED
|
0
|
1
|
|
Extension Phase (Up to 28 Months)
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Participants With Normal Hepatic Function
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
PK Phase (Up to Day 8)
Physician Decision
|
0
|
1
|
|
PK Phase (Up to Day 8)
Adverse Event
|
1
|
0
|
|
Extension Phase (Up to 28 Months)
Death
|
2
|
4
|
|
Extension Phase (Up to 28 Months)
Withdrawal by Subject
|
1
|
2
|
|
Extension Phase (Up to 28 Months)
Disease Progression
|
5
|
0
|
Baseline Characteristics
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Baseline characteristics by cohort
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 6.69 • n=99 Participants
|
63.6 Years
STANDARD_DEVIATION 7.71 • n=107 Participants
|
64.2 Years
STANDARD_DEVIATION 6.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population consisted of all participants who have received niraparib and have sufficient evaluable samples
Blood samples were collected at indicated time points to evaluate AUC (last) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase
Niraparib
|
18500 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 37.7
|
26800 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 49.6
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase
M1
|
19000 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 27.5
|
12400 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 55.0
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points to evaluate AUC (0-infinity) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=7 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC 0-infinity) of Niraparib and M1 During PK Phase
Niraparib, n= 9, 7
|
19700 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 38.7
|
30800 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 54.3
|
|
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC 0-infinity) of Niraparib and M1 During PK Phase
M1, n=9, 3
|
20700 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 29.8
|
21500 Hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 25.4
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population
Blood samples were collected at indicated time points to evaluate Cmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) of Niraparib and M1 During PK Phase
Niraparib
|
594 Nanogram per milliliter
Geometric Coefficient of Variation 45.6
|
553 Nanogram per milliliter
Geometric Coefficient of Variation 47.4
|
|
Observed Maximum Plasma Concentration (Cmax) of Niraparib and M1 During PK Phase
M1
|
398 Nanogram per milliliter
Geometric Coefficient of Variation 17.6
|
151 Nanogram per milliliter
Geometric Coefficient of Variation 89.3
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population
Blood samples were collected at indicated time points to evaluate tmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Time to Maximum Concentration (Tmax) of Niraparib and M1 During PK Phase
Niraparib
|
4.00 Hour
Interval 3.0 to 6.33
|
4.09 Hour
Interval 2.0 to 8.02
|
|
Time to Maximum Concentration (Tmax) of Niraparib and M1 During PK Phase
M1
|
6.00 Hour
Interval 4.0 to 12.08
|
17.73 Hour
Interval 6.0 to 25.17
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points to evaluate t1/2 of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=7 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Terminal Half-life (t½) of Niraparib and M1 During PK Phase
Niraparib, n=9, 7
|
43.9 Hour
Geometric Coefficient of Variation 11.5
|
54.8 Hour
Geometric Coefficient of Variation 25.8
|
|
Terminal Half-life (t½) of Niraparib and M1 During PK Phase
M1, n=9, 3
|
47.9 Hour
Geometric Coefficient of Variation 16.6
|
43.7 Hour
Geometric Coefficient of Variation 20.7
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1Population: PK population. Only those participants with data available at specified data points were analyzed. CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
CL/F is calculated as Dose/(AUC 0-inf). Blood samples were collected at indicated time points to evaluate CL/F of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis. Not applicable (NA) indicates that CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=7 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Niraparib and M1 During PK Phase
Niraparib
|
15.2 Liters per hour
Geometric Coefficient of Variation 38.7
|
9.74 Liters per hour
Geometric Coefficient of Variation 54.3
|
|
Apparent Total Body Clearance (CL/F) of Niraparib and M1 During PK Phase
M1
|
NA Liters per hour
Geometric Coefficient of Variation NA
NA indicates that CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
|
NA Liters per hour
Geometric Coefficient of Variation NA
NA indicates that CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
|
SECONDARY outcome
Timeframe: Up to Day 8Population: Safety Population for PK phase consisted of all participants who received atleast one dose of the investigational drug niraparib during the PK phase.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. SAE is defined as 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Including Non-serious Adverse Events (Non-SAEs), Serious Adverse Events (SAEs) and Discontinuations Due to AEs During PK Phase
Any Non -SAEs
|
5 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Including Non-serious Adverse Events (Non-SAEs), Serious Adverse Events (SAEs) and Discontinuations Due to AEs During PK Phase
Any SAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Including Non-serious Adverse Events (Non-SAEs), Serious Adverse Events (SAEs) and Discontinuations Due to AEs During PK Phase
Any Discontinuations due to AE
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and at Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Hemoglobin (Hb) During PK Phase
|
-0.5 Grams per liter
Standard Deviation 7.82
|
0.6 Grams per liter
Standard Deviation 7.65
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected to analyze hematology parameters:Leukocyte, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Lymphocytes
|
0.2 10^9 cells per liter
Standard Deviation 0.38
|
-0.1 10^9 cells per liter
Standard Deviation 0.15
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Monocytes
|
0.1 10^9 cells per liter
Standard Deviation 0.32
|
-0.1 10^9 cells per liter
Standard Deviation 0.24
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Neutrophils
|
-0.5 10^9 cells per liter
Standard Deviation 2.13
|
-0.7 10^9 cells per liter
Standard Deviation 1.89
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Platelets
|
-18.4 10^9 cells per liter
Standard Deviation 95.41
|
-23.4 10^9 cells per liter
Standard Deviation 60.31
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Leukocyte
|
-0.2 10^9 cells per liter
Standard Deviation 2.04
|
-0.8 10^9 cells per liter
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During PK Phase
Protein
|
-1.0 Grams per liter
Standard Deviation 4.24
|
-3.5 Grams per liter
Standard Deviation 5.55
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During PK Phase
Albumin
|
-0.9 Grams per liter
Standard Deviation 2.03
|
-2.3 Grams per liter
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LDH) During PK Phase
Alkaline phosphatase
|
26.3 International units per Liter
Standard Deviation 50.67
|
-32.6 International units per Liter
Standard Deviation 219.03
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LDH) During PK Phase
AST
|
34.6 International units per Liter
Standard Deviation 94.42
|
-6.4 International units per Liter
Standard Deviation 43.81
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LDH) During PK Phase
ALT
|
24.3 International units per Liter
Standard Deviation 60.82
|
-4.4 International units per Liter
Standard Deviation 10.39
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LDH) During PK Phase
LDH
|
36.0 International units per Liter
Standard Deviation 134.66
|
-58.5 International units per Liter
Standard Deviation 137.97
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=7 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During PK Phase
|
74.4 Units per Liter
Standard Deviation 206.90
|
0.3 Units per Liter
Standard Deviation 22.92
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed.
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During PK Phase
Bilirubin
|
0.6 Micromoles per liter
Standard Deviation 3.41
|
8.3 Micromoles per liter
Standard Deviation 9.47
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During PK Phase
Creatinine
|
-1.9 Micromoles per liter
Standard Deviation 10.87
|
-0.7 Micromoles per liter
Standard Deviation 17.19
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Glucose, n=8, 8
|
-0.8 Millimoles per liter
Standard Deviation 1.14
|
-0.5 Millimoles per liter
Standard Deviation 1.61
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Calcium, n=8, 8
|
0.0 Millimoles per liter
Standard Deviation 0.17
|
-0.1 Millimoles per liter
Standard Deviation 0.15
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Chloride, n=8, 8
|
1.8 Millimoles per liter
Standard Deviation 2.25
|
-0.3 Millimoles per liter
Standard Deviation 1.83
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Phosphate, n=8, 8
|
0.1 Millimoles per liter
Standard Deviation 0.16
|
-0.1 Millimoles per liter
Standard Deviation 0.14
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Potassium, n=8, 8
|
-0.2 Millimoles per liter
Standard Deviation 0.26
|
-0.2 Millimoles per liter
Standard Deviation 0.74
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Sodium, n=8, 8
|
1.6 Millimoles per liter
Standard Deviation 2.26
|
-0.5 Millimoles per liter
Standard Deviation 2.78
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
BUN, n=8, 8
|
-0.4 Millimoles per liter
Standard Deviation 1.66
|
-0.1 Millimoles per liter
Standard Deviation 0.97
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Magnesium, n=8, 7
|
-0.0 Millimoles per liter
Standard Deviation 0.09
|
0.0 Millimoles per liter
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Day 8Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Weight During PK Phase
Day 2, n=8, 6
|
-0.0 Kilograms
Standard Deviation 0.58
|
0.8 Kilograms
Standard Deviation 0.87
|
|
Change From Baseline in Weight During PK Phase
Day 8, n=9, 8
|
-0.0 Kilograms
Standard Deviation 1.14
|
0.3 Kilograms
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Day 8Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During PK Phase
SBP, Day 2, n=9, 7
|
5.9 Millimeters of mercury
Standard Deviation 10.79
|
5.7 Millimeters of mercury
Standard Deviation 10.23
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During PK Phase
SBP, Day 8, n=9, 8
|
0.9 Millimeters of mercury
Standard Deviation 18.58
|
0.3 Millimeters of mercury
Standard Deviation 9.69
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During PK Phase
DBP, Day 2, n=9, 7
|
3.6 Millimeters of mercury
Standard Deviation 8.38
|
2.7 Millimeters of mercury
Standard Deviation 3.15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During PK Phase
DBP, Day 8, n=9, 8
|
2.4 Millimeters of mercury
Standard Deviation 9.08
|
-0.1 Millimeters of mercury
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Day 8Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Pulse Rate During PK Phase
Day 2, n=9, 7
|
8.9 Beats per minute
Standard Deviation 11.30
|
1.3 Beats per minute
Standard Deviation 10.58
|
|
Change From Baseline in Pulse Rate During PK Phase
Day 8, n=9, 8
|
2.8 Beats per minute
Standard Deviation 11.91
|
-2.3 Beats per minute
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Day 8Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital sign including body temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=9 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=8 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Body Temperature During PK Phase
Day 2, n=9, 7
|
-0.0 Degrees Celsius
Standard Deviation 0.39
|
0.1 Degrees Celsius
Standard Deviation 0.24
|
|
Change From Baseline in Body Temperature During PK Phase
Day 8, n=9, 8
|
0.1 Degrees Celsius
Standard Deviation 0.33
|
0.1 Degrees Celsius
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Safety Population for extension phase consisted of all participants who received atleast one dose of the investigational drug niraparib during the extension phase.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. SAE is defined as 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=7 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Number of Participants With TEAE Including Non-SAEs, SAEs and Discontinuations Due to AEs During Extension Phase
Any Non-SAEs
|
8 Participants
|
7 Participants
|
|
Number of Participants With TEAE Including Non-SAEs, SAEs and Discontinuations Due to AEs During Extension Phase
Any SAE
|
3 Participants
|
2 Participants
|
|
Number of Participants With TEAE Including Non-SAEs, SAEs and Discontinuations Due to AEs During Extension Phase
Any Discontinuations due to AE
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 (Days 8, 15, 21), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=5 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Hb During Extension Phase
Cycle 1 Day 8, n=8, 5
|
4.3 Grams per liter
Standard Deviation 5.78
|
1.0 Grams per liter
Standard Deviation 8.89
|
|
Change From Baseline in Hb During Extension Phase
Cycle 1 Day 15, n=8, 4
|
-0.5 Grams per liter
Standard Deviation 6.32
|
-8.3 Grams per liter
Standard Deviation 15.73
|
|
Change From Baseline in Hb During Extension Phase
Cycle 1 Day 21, n=7, 4
|
-2.6 Grams per liter
Standard Deviation 12.91
|
-22.3 Grams per liter
Standard Deviation 17.19
|
|
Change From Baseline in Hb During Extension Phase
Cycle 2 Day 1, n=6, 2
|
-8.0 Grams per liter
Standard Deviation 14.93
|
-15.0 Grams per liter
Standard Deviation 1.41
|
|
Change From Baseline in Hb During Extension Phase
Cycle 3 Day 1, n=3, 1
|
-16.7 Grams per liter
Standard Deviation 12.10
|
-10.0 Grams per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Hb During Extension Phase
Cycle 4 Day 1, n=3, 0
|
-10.7 Grams per liter
Standard Deviation 11.06
|
—
|
|
Change From Baseline in Hb During Extension Phase
Cycle 5 Day 1, n=3, 0
|
-3.7 Grams per liter
Standard Deviation 2.08
|
—
|
|
Change From Baseline in Hb During Extension Phase
Cycle 6 Day1, n=2, 0
|
3.0 Grams per liter
Standard Deviation 7.07
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 (Days 8, 15, 21), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze hematology parameters: Lymphocytes, Leukocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=8 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=5 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 1 Day 8, n=7, 5
|
-0.2 10^9 cells per liter
Standard Deviation 0.36
|
-0.1 10^9 cells per liter
Standard Deviation 0.22
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 1 Day 15, n=8, 4
|
-0.1 10^9 cells per liter
Standard Deviation 0.37
|
-0.0 10^9 cells per liter
Standard Deviation 0.48
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 1 Day 21, n=7, 4
|
-0.1 10^9 cells per liter
Standard Deviation 0.25
|
-0.2 10^9 cells per liter
Standard Deviation 0.20
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 2 Day 1, n=6, 2
|
-0.1 10^9 cells per liter
Standard Deviation 0.33
|
0.1 10^9 cells per liter
Standard Deviation 0.04
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 3 Day 1, n=3, 1
|
-0.3 10^9 cells per liter
Standard Deviation 0.24
|
0.2 10^9 cells per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 4 Day 1, n=3, 0
|
0.0 10^9 cells per liter
Standard Deviation 0.33
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 5 Day 1, n=3, 0
|
0.3 10^9 cells per liter
Standard Deviation 0.30
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Lymphocytes, Cycle 6 Day1, n=2, 0
|
-0.0 10^9 cells per liter
Standard Deviation 0.54
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 1 Day 8, n=7, 5
|
-0.1 10^9 cells per liter
Standard Deviation 0.20
|
0.0 10^9 cells per liter
Standard Deviation 0.11
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 1 Day 15, n=8, 4
|
-0.2 10^9 cells per liter
Standard Deviation 0.28
|
-0.1 10^9 cells per liter
Standard Deviation 0.22
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 1 Day 21, n=7, 4
|
-0.2 10^9 cells per liter
Standard Deviation 0.20
|
-0.1 10^9 cells per liter
Standard Deviation 0.40
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 2 Day 1, n=6, 2
|
-0.1 10^9 cells per liter
Standard Deviation 0.14
|
-0.1 10^9 cells per liter
Standard Deviation 0.16
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 3 Day 1, n=3, 1
|
-0.2 10^9 cells per liter
Standard Deviation 0.06
|
0.0 10^9 cells per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 4 Day 1, n=3, 0
|
-0.0 10^9 cells per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 5 Day 1, n=3, 0
|
-0.1 10^9 cells per liter
Standard Deviation 0.10
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Monocytes, Cycle 6 Day1, n=2, 0
|
-0.1 10^9 cells per liter
Standard Deviation 0.16
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 1 Day 8, n=7, 5
|
0.4 10^9 cells per liter
Standard Deviation 0.87
|
0.4 10^9 cells per liter
Standard Deviation 0.44
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 1 Day 15, n=8, 4
|
0.3 10^9 cells per liter
Standard Deviation 1.01
|
0.5 10^9 cells per liter
Standard Deviation 0.73
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 1 Day 21, n=7, 4
|
-0.6 10^9 cells per liter
Standard Deviation 1.92
|
-0.2 10^9 cells per liter
Standard Deviation 0.81
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 2 Day 1, n=6, 2
|
0.6 10^9 cells per liter
Standard Deviation 2.03
|
-1.8 10^9 cells per liter
Standard Deviation 1.94
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 3 Day 1, n=3, 1
|
-0.0 10^9 cells per liter
Standard Deviation 1.70
|
-0.5 10^9 cells per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 4 Day 1, n=3, 0
|
-0.4 10^9 cells per liter
Standard Deviation 0.51
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 5 Day 1, n=3, 0
|
0.5 10^9 cells per liter
Standard Deviation 0.27
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Neutrophils, Cycle 6 Day1, n=2, 0
|
-0.1 10^9 cells per liter
Standard Deviation 0.78
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 1 Day 8, n=8, 5
|
12.0 10^9 cells per liter
Standard Deviation 21.75
|
-0.8 10^9 cells per liter
Standard Deviation 21.32
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 1 Day 15, n=8, 4
|
-58.1 10^9 cells per liter
Standard Deviation 118.98
|
-8.3 10^9 cells per liter
Standard Deviation 63.33
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 1 Day 21, n=7, 4
|
-81.9 10^9 cells per liter
Standard Deviation 113.91
|
-19.3 10^9 cells per liter
Standard Deviation 57.70
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 2 Day 1, n=6, 2
|
55.3 10^9 cells per liter
Standard Deviation 128.24
|
-102.5 10^9 cells per liter
Standard Deviation 130.81
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 3 Day 1, n=3, 1
|
-46.3 10^9 cells per liter
Standard Deviation 36.46
|
59.0 10^9 cells per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 4 Day 1, n=3, 0
|
34.0 10^9 cells per liter
Standard Deviation 43.92
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 5 Day 1, n=3, 0
|
45.7 10^9 cells per liter
Standard Deviation 22.68
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Platelets, Cycle 6 Day1, n=2, 0
|
34.0 10^9 cells per liter
Standard Deviation 42.43
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 1 Day 8, n=8, 5
|
0.4 10^9 cells per liter
Standard Deviation 1.76
|
0.3 10^9 cells per liter
Standard Deviation 0.40
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 1 Day 15, n=8, 4
|
-0.1 10^9 cells per liter
Standard Deviation 1.25
|
0.4 10^9 cells per liter
Standard Deviation 1.28
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 1 Day 21, n=7, 4
|
-1.0 10^9 cells per liter
Standard Deviation 2.05
|
-0.5 10^9 cells per liter
Standard Deviation 1.36
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 2 Day 1, n=6, 2
|
0.5 10^9 cells per liter
Standard Deviation 1.96
|
-1.9 10^9 cells per liter
Standard Deviation 1.91
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 3 Day 1, n=3, 1
|
-0.5 10^9 cells per liter
Standard Deviation 1.67
|
-0.2 10^9 cells per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 4 Day 1, n=3, 0
|
-0.4 10^9 cells per liter
Standard Deviation 0.76
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 5 Day 1, n=3, 0
|
0.9 10^9 cells per liter
Standard Deviation 0.31
|
—
|
|
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Leukocytes, Cycle 6 Day1, n=2, 0
|
-0.3 10^9 cells per liter
Standard Deviation 1.48
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Protein, Cycle 2 Day 1, n=6, 2
|
-1.0 Grams per liter
Standard Deviation 6.96
|
-2.0 Grams per liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Protein, Cycle 3 Day 1, n=3, 1
|
-2.0 Grams per liter
Standard Deviation 3.46
|
-5.0 Grams per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Protein, Cycle 4 Day 1, n=3, 0
|
1.0 Grams per liter
Standard Deviation 3.61
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Protein, Cycle 5 Day 1, n=3, 0
|
4.0 Grams per liter
Standard Deviation 2.65
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Protein, Cycle 6 Day1, n=2, 0
|
0.0 Grams per liter
Standard Deviation 2.83
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Albumin, Cycle 2 Day 1, n=6, 2
|
0.3 Grams per liter
Standard Deviation 4.37
|
-1.0 Grams per liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Albumin, Cycle 3 Day 1, n=3, 1
|
1.0 Grams per liter
Standard Deviation 2.65
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Albumin, Cycle 4 Day 1, n=3, 0
|
2.7 Grams per liter
Standard Deviation 3.21
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Albumin, Cycle 5 Day 1, n=3, 0
|
4.7 Grams per liter
Standard Deviation 2.52
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Albumin, Cycle 6 Day1, n=2, 0
|
17.0 Grams per liter
Standard Deviation 16.97
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Alkaline Phosphatase, Cycle 2 Day 1, n=6, 2
|
23.3 International units per Liter
Standard Deviation 17.43
|
-53.5 International units per Liter
Standard Deviation 221.32
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Alkaline Phosphatase, Cycle 3 Day 1, n=3, 1
|
19.7 International units per Liter
Standard Deviation 5.03
|
57.0 International units per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Alkaline Phosphatase, Cycle 4 Day 1, n=3, 0
|
20.0 International units per Liter
Standard Deviation 10.54
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Alkaline Phosphatase, Cycle 5 Day 1, n=3, 0
|
12.0 International units per Liter
Standard Deviation 14.80
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Alkaline Phosphatase, Cycle 6 Day1, n=2, 0
|
1.5 International units per Liter
Standard Deviation 16.26
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
ALT, Cycle 2 Day 1, n=6, 2
|
11.8 International units per Liter
Standard Deviation 19.77
|
-6.5 International units per Liter
Standard Deviation 20.51
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
ALT, Cycle 3 Day 1, n=3, 1
|
4.7 International units per Liter
Standard Deviation 6.11
|
4.0 International units per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
ALT, Cycle 4 Day 1, n=3, 0
|
2.0 International units per Liter
Standard Deviation 5.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
ALT, Cycle 5 Day 1, n=3, 0
|
5.3 International units per Liter
Standard Deviation 7.02
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
ALT, Cycle 6 Day1, n=2, 0
|
2.0 International units per Liter
Standard Deviation 4.24
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
AST, Cycle 2 Day 1, n=6, 2
|
4.8 International units per Liter
Standard Deviation 5.81
|
-25.0 International units per Liter
Standard Deviation 38.18
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
AST, Cycle 3 Day 1, n=3, 1
|
2.0 International units per Liter
Standard Deviation 2.65
|
4.0 International units per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
AST, Cycle 4 Day 1, n=3, 0
|
4.3 International units per Liter
Standard Deviation 2.31
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
AST, Cycle 5 Day 1, n=3, 0
|
5.3 International units per Liter
Standard Deviation 2.52
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
AST, Cycle 6 Day1, n=2, 0
|
5.5 International units per Liter
Standard Deviation 4.95
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
LDH, Cycle 2 Day 1, n=3, 2
|
11.7 International units per Liter
Standard Deviation 37.53
|
-625.0 International units per Liter
Standard Deviation 847.11
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
LDH, Cycle 3 Day 1, n=3, 1
|
6.7 International units per Liter
Standard Deviation 17.56
|
-9.0 International units per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
LDH, Cycle 4 Day 1, n=3, 0
|
-11.7 International units per Liter
Standard Deviation 41.77
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
LDH, Cycle 5 Day 1, n=3, 0
|
-5.3 International units per Liter
Standard Deviation 21.46
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
LDH, Cycle 6 Day1, n=2, 0
|
19.0 International units per Liter
Standard Deviation 35.36
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=4 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Cycle 2 Day 1, n=4, 2
|
-1.0 Units per Liter
Standard Deviation 16.39
|
-2.5 Units per Liter
Standard Deviation 6.36
|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Cycle 3 Day 1, n=3, 1
|
-7.0 Units per Liter
Standard Deviation 14.18
|
-4.0 Units per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Cycle 4 Day 1, n=3, 0
|
-2.3 Units per Liter
Standard Deviation 16.77
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Cycle 5 Day 1, n=3, 0
|
3.0 Units per Liter
Standard Deviation 5.57
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Cycle 6 Day1, n=2, 0
|
-2.5 Units per Liter
Standard Deviation 31.82
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Bilirubin, Cycle 2 Day 1, n=6, 2
|
0.9 Micromoles per liter
Standard Deviation 1.79
|
-6.0 Micromoles per liter
Standard Deviation 8.46
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Bilirubin, Cycle 3 Day 1, n=3, 1
|
0.6 Micromoles per liter
Standard Deviation 2.61
|
1.7 Micromoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Bilirubin, Cycle 4 Day 1, n=3, 0
|
0.6 Micromoles per liter
Standard Deviation 0.99
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Bilirubin, Cycle 5 Day 1, n=3, 0
|
2.9 Micromoles per liter
Standard Deviation 0.99
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Bilirubin, Cycle 6 Day1, n=2, 0
|
-0.9 Micromoles per liter
Standard Deviation 1.21
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Creatinine, Cycle 2 Day 1, n=6, 2
|
7.5 Micromoles per liter
Standard Deviation 17.93
|
18.1 Micromoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Creatinine, Cycle 3 Day 1, n=3, 1
|
13.0 Micromoles per liter
Standard Deviation 5.03
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Creatinine, Cycle 4 Day 1, n=3, 0
|
0.9 Micromoles per liter
Standard Deviation 9.56
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Creatinine, Cycle 5 Day 1, n=3, 0
|
5.6 Micromoles per liter
Standard Deviation 2.84
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Creatinine, Cycle 6 Day1, n=2, 0
|
5.7 Micromoles per liter
Standard Deviation 5.63
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Phosphate, Cycle 4 Day 1, n=3, 0
|
-0.1 Millimoles per liter
Standard Deviation 0.26
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Phosphate, Cycle 5 Day 1, n=3, 0
|
0.0 Millimoles per liter
Standard Deviation 0.43
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Phosphate, Cycle 6 Day1, n=2, 0
|
0.0 Millimoles per liter
Standard Deviation 0.30
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Calcium, Cycle 3 Day 1, n=3, 1
|
0.0 Millimoles per liter
Standard Deviation 0.06
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Calcium, Cycle 4 Day 1, n=3, 0
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Calcium, Cycle 5 Day 1, n=3, 0
|
0.1 Millimoles per liter
Standard Deviation 0.10
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Calcium, Cycle 6 Day1, n=2, 0
|
-0.0 Millimoles per liter
Standard Deviation 0.02
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Chloride, Cycle 2 Day 1, n=6, 2
|
-1.7 Millimoles per liter
Standard Deviation 2.25
|
-3.5 Millimoles per liter
Standard Deviation 2.12
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Chloride, Cycle 3 Day 1, n=3, 1
|
-2.0 Millimoles per liter
Standard Deviation 3.61
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Chloride, Cycle 4 Day 1, n=3, 0
|
-0.7 Millimoles per liter
Standard Deviation 1.53
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Chloride, Cycle 5 Day 1, n=3, 0
|
-1.7 Millimoles per liter
Standard Deviation 1.15
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Chloride, Cycle 6 Day1, n=2, 0
|
-2.5 Millimoles per liter
Standard Deviation 2.12
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Phosphate, Cycle 2 Day 1, n=5, 2
|
-0.2 Millimoles per liter
Standard Deviation 0.34
|
0.3 Millimoles per liter
Standard Deviation 0.02
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Phosphate, Cycle 3 Day 1, n=3, 1
|
0.0 Millimoles per liter
Standard Deviation 0.18
|
-0.1 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Potassium, Cycle 2 Day 1, n=6, 2
|
-0.2 Millimoles per liter
Standard Deviation 0.12
|
0.1 Millimoles per liter
Standard Deviation 0.21
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Potassium, Cycle 3 Day 1, n=3, 1
|
0.1 Millimoles per liter
Standard Deviation 0.30
|
0.4 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Glucose, Cycle 2 Day 1, n=6, 2
|
-0.0 Millimoles per liter
Standard Deviation 1.45
|
1.6 Millimoles per liter
Standard Deviation 0.47
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Glucose, Cycle 3 Day 1, n=3, 1
|
0.7 Millimoles per liter
Standard Deviation 1.50
|
-2.3 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Glucose, Cycle 4 Day 1, n=3, 0
|
-0.4 Millimoles per liter
Standard Deviation 0.95
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Glucose, Cycle 5 Day 1, n=3, 0
|
-0.7 Millimoles per liter
Standard Deviation 0.90
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Glucose, Cycle 6 Day1, n=2, 0
|
-0.8 Millimoles per liter
Standard Deviation 0.90
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Calcium, Cycle 2 Day 1, n=6, 2
|
-0.0 Millimoles per liter
Standard Deviation 0.16
|
0.0 Millimoles per liter
Standard Deviation 0.14
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Potassium, Cycle 4 Day 1, n=3, 0
|
0.0 Millimoles per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Potassium, Cycle 5 Day 1, n=3, 0
|
0.1 Millimoles per liter
Standard Deviation 0.38
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Potassium, Cycle 6 Day1, n=2, 0
|
0.1 Millimoles per liter
Standard Deviation 0.21
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Sodium, Cycle 2 Day 1, n=6, 2
|
-1.8 Millimoles per liter
Standard Deviation 1.17
|
-1.5 Millimoles per liter
Standard Deviation 2.12
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Sodium, Cycle 3 Day 1, n=3, 1
|
-3.0 Millimoles per liter
Standard Deviation 1.73
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Sodium, Cycle 4 Day 1, n=3, 0
|
-1.0 Millimoles per liter
Standard Deviation 1.73
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Sodium, Cycle 5 Day 1, n=3, 0
|
-1.7 Millimoles per liter
Standard Deviation 0.58
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Sodium, Cycle 6 Day1, n=2, 0
|
-1.5 Millimoles per liter
Standard Deviation 2.12
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
BUN, Cycle 2 Day 1, n=6, 2
|
0.3 Millimoles per liter
Standard Deviation 2.15
|
1.8 Millimoles per liter
Standard Deviation 0.50
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
BUN, Cycle 3 Day 1, n=3, 1
|
0.7 Millimoles per liter
Standard Deviation 2.14
|
1.4 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
BUN, Cycle 4 Day 1, n=3, 0
|
-1.0 Millimoles per liter
Standard Deviation 0.90
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
BUN, Cycle 5 Day 1, n=3, 0
|
-0.5 Millimoles per liter
Standard Deviation 1.25
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
BUN, Cycle 6 Day1, n=2, 0
|
-0.5 Millimoles per liter
Standard Deviation 0.76
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Magnesium, Cycle 2 Day 1, n=5, 2
|
-0.0 Millimoles per liter
Standard Deviation 0.09
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Magnesium, Cycle 3 Day 1, n=3, 1
|
-0.0 Millimoles per liter
Standard Deviation 0.04
|
0.1 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Magnesium, Cycle 4 Day 1, n=2, 0
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Magnesium, Cycle 5 Day 1, n=2, 0
|
0.1 Millimoles per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Magnesium, Cycle 6 Day1, n=1, 0
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Weight During Extension Phase
Cycle 2 Day 1, n=6, 2
|
-1.6 Kilograms
Standard Deviation 1.74
|
-4.6 Kilograms
Standard Deviation 4.31
|
|
Change From Baseline in Weight During Extension Phase
Cycle 3 Day 1, n=3, 1
|
-0.3 Kilograms
Standard Deviation 1.00
|
-4.5 Kilograms
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Weight During Extension Phase
Cycle 4 Day 1, n=3, 0
|
-2.3 Kilograms
Standard Deviation 0.85
|
—
|
|
Change From Baseline in Weight During Extension Phase
Cycle 5 Day 1, n=3, 0
|
-3.3 Kilograms
Standard Deviation 2.91
|
—
|
|
Change From Baseline in Weight During Extension Phase
Cycle 6 Day1, n=2, 0
|
-0.4 Kilograms
Standard Deviation 0.92
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in SBP and DBP During Extension Phase
DBP, Cycle 2 Day 1, n=6, 2
|
-0.2 Millimeters of mercury
Standard Deviation 3.19
|
-12.0 Millimeters of mercury
Standard Deviation 12.73
|
|
Change From Baseline in SBP and DBP During Extension Phase
DBP, Cycle 3 Day 1, n=3, 1
|
8.7 Millimeters of mercury
Standard Deviation 9.81
|
-9.0 Millimeters of mercury
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in SBP and DBP During Extension Phase
DBP, Cycle 4 Day 1, n=3, 0
|
-0.3 Millimeters of mercury
Standard Deviation 3.06
|
—
|
|
Change From Baseline in SBP and DBP During Extension Phase
DBP, Cycle 5 Day 1, n=3, 0
|
12.3 Millimeters of mercury
Standard Deviation 6.51
|
—
|
|
Change From Baseline in SBP and DBP During Extension Phase
DBP, Cycle 6 Day1, n=2, 0
|
6.5 Millimeters of mercury
Standard Deviation 4.95
|
—
|
|
Change From Baseline in SBP and DBP During Extension Phase
SBP, Cycle 2 Day 1, n=6, 2
|
-1.2 Millimeters of mercury
Standard Deviation 12.89
|
-2.5 Millimeters of mercury
Standard Deviation 23.33
|
|
Change From Baseline in SBP and DBP During Extension Phase
SBP, Cycle 3 Day 1, n=3, 1
|
6.7 Millimeters of mercury
Standard Deviation 10.97
|
-6.0 Millimeters of mercury
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in SBP and DBP During Extension Phase
SBP, Cycle 4 Day 1, n=3, 0
|
-2.3 Millimeters of mercury
Standard Deviation 7.57
|
—
|
|
Change From Baseline in SBP and DBP During Extension Phase
SBP, Cycle 5 Day 1, n=3, 0
|
5.7 Millimeters of mercury
Standard Deviation 10.02
|
—
|
|
Change From Baseline in SBP and DBP During Extension Phase
SBP, Cycle 6 Day1, n=2, 0
|
13.0 Millimeters of mercury
Standard Deviation 1.41
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Pulse Rate During Extension Phase
Cycle 2 Day 1, n=6, 2
|
17.2 Beats per minute
Standard Deviation 10.15
|
9.0 Beats per minute
Standard Deviation 5.66
|
|
Change From Baseline in Pulse Rate During Extension Phase
Cycle 3 Day 1, n=3, 1
|
23.0 Beats per minute
Standard Deviation 20.78
|
4.0 Beats per minute
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Pulse Rate During Extension Phase
Cycle 4 Day 1, n=3, 0
|
15.3 Beats per minute
Standard Deviation 8.08
|
—
|
|
Change From Baseline in Pulse Rate During Extension Phase
Cycle 5 Day 1, n=3, 0
|
9.3 Beats per minute
Standard Deviation 11.55
|
—
|
|
Change From Baseline in Pulse Rate During Extension Phase
Cycle 6 Day1, n=2, 0
|
16.5 Beats per minute
Standard Deviation 9.19
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Vital sign including temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Outcome measures
| Measure |
Participants With Normal Hepatic Function
n=6 Participants
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function
n=2 Participants
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|
|
Change From Baseline in Temperature During Extension Phase
Cycle 2 Day 1, n=6, 2
|
-0.3 Degrees Celsius
Standard Deviation 0.77
|
0.1 Degrees Celsius
Standard Deviation 0.07
|
|
Change From Baseline in Temperature During Extension Phase
Cycle 3 Day 1, n=3, 1
|
-0.1 Degrees Celsius
Standard Deviation 0.26
|
0.0 Degrees Celsius
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Temperature During Extension Phase
Cycle 4 Day 1, n=3, 0
|
-0.0 Degrees Celsius
Standard Deviation 0.38
|
—
|
|
Change From Baseline in Temperature During Extension Phase
Cycle 5 Day 1, n=3, 0
|
-0.1 Degrees Celsius
Standard Deviation 0.21
|
—
|
|
Change From Baseline in Temperature During Extension Phase
Cycle 6 Day1, n=2, 0
|
-0.3 Degrees Celsius
Standard Deviation 0.21
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 3 hours and 168 hours post dose Day 1Population: PK population.
Unbound fraction is the unbound concentration of niraparib and M1 in plasma divided by total concentration. This analysis was planned but not performed due to insufficient participants with data
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 3 hours and 168 hours post dose Day 1Population: PK population.
CLfu/F is the clearance for unbound niraparib and M1. This analysis was planned but not performed due to insufficient participants with data
Outcome measures
Outcome data not reported
Adverse Events
Participants With Normal Hepatic Function-PK Phase
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Participants With Impaired Hepatic Function-PK Phase
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Participants With Normal Hepatic Function-Extension Phase
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Participants With Impaired Hepatic Function-Extension Phase
Serious events: 2 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Participants With Normal Hepatic Function-PK Phase
n=9 participants at risk
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function-PK Phase
n=8 participants at risk
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Normal Hepatic Function-Extension Phase
n=8 participants at risk
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function-Extension Phase
n=7 participants at risk
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
Other adverse events
| Measure |
Participants With Normal Hepatic Function-PK Phase
n=9 participants at risk
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function-PK Phase
n=8 participants at risk
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Normal Hepatic Function-Extension Phase
n=8 participants at risk
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
Participants With Impaired Hepatic Function-Extension Phase
n=7 participants at risk
All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Amylase increased
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
50.0%
4/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Fatigue
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
87.5%
7/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
71.4%
5/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Taste disorder
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Lipase increased
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
42.9%
3/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
37.5%
3/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
71.4%
5/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
71.4%
5/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
50.0%
4/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
42.9%
3/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
42.9%
3/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Asthenia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
28.6%
2/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
25.0%
2/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
37.5%
3/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
12.5%
1/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
14.3%
1/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
11.1%
1/9 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/8 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.
All cause mortality, non-SAEs and SAEs were reported for Safety Population consisting of all participants who received atleast 1 dose of the investigational drug, niraparib. The results are presented based on final analysis up to 28 months.
|
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