Trial Outcomes & Findings for Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP) (NCT NCT04544995)
NCT ID: NCT04544995
Last Updated: 2026-01-21
Results Overview
DLT referred to adverse effects within the first 42 days of treatment, indicating the maximum tolerated dose. DLTs included treatment-related Grade (G) 4 non-haematologic AEs or G3 AEs unresolved to G≤1 within 48 hours. G3/4 non-haematologic lab abnormalities were DLTs if causing hospitalization or persisting ≥7 days with symptoms or requiring intervention. Haematologic DLTs included prolonged G4 thrombocytopenia, G3/4 thrombocytopenia with bleeding or transfusion needs, prolonged G4 neutropenia, G3/4 neutropenia with infection, and G3/4 anemia requiring transfusion. Other criteria included Cycle 2 delays \>2 weeks, unresolved G≥2 uveitis/endocrine toxicity, persistent colitis/diarrhea, unresolved G3/4 immune-related AEs, G≥3 infusion reactions, hemophagocytic lymphohistiocytosis, posterior reversible encephalopathy syndrome, and treatment-related G5 AE. DLT-evaluable participants completed ≥2 cycles with ≥80% of planned niraparib and ≥2 dostarlimab infusions or had a DLT.
TERMINATED
PHASE1
47 participants
Up to 42 days
2026-01-21
Participant Flow
This study was performed in two parts: Part 1: Dose Escalation and Part 2: Safety Run-in and Cohort Expansion.
Participant milestones
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (age-based dose) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
Paediatric participants with recurrent or refractory osteosarcoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
Paediatric participants with recurrent or refractory neuroblastoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory osteosarcoma or neuroblastoma received niraparib (dose based on weight) tablet for oral suspension (TfOS) orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
5
|
3
|
11
|
7
|
3
|
|
Overall Study
DLT-Evaluable Population
|
8
|
6
|
2
|
2
|
0
|
0
|
3
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
11
|
6
|
5
|
3
|
0
|
0
|
3
|
|
Overall Study
Modified Intent-to-Treat (mITT) Population
|
0
|
0
|
0
|
0
|
9
|
8
|
0
|
|
Overall Study
Pharmacokinetic (PK) Population
|
11
|
7
|
5
|
3
|
11
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
5
|
3
|
11
|
7
|
3
|
Reasons for withdrawal
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (age-based dose) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
Paediatric participants with recurrent or refractory osteosarcoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
Paediatric participants with recurrent or refractory neuroblastoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory osteosarcoma or neuroblastoma received niraparib (dose based on weight) tablet for oral suspension (TfOS) orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
7
|
3
|
3
|
3
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Reached protocol-defined stopping criteria
|
3
|
4
|
2
|
0
|
4
|
4
|
1
|
Baseline Characteristics
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
Baseline characteristics by cohort
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
n=11 Participants
Paediatric participants with recurrent or refractory osteosarcoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
n=7 Participants
Paediatric participants with recurrent or refractory neuroblastoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory osteosarcoma or neuroblastoma received niraparib (dose based on weight) tablet for oral suspension (TfOS) orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=121 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=33 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=33 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
13.9 YEARS
STANDARD_DEVIATION 2.84 • n=37 Participants
|
13.7 YEARS
STANDARD_DEVIATION 3.99 • n=44 Participants
|
13.0 YEARS
STANDARD_DEVIATION 3.81 • n=40 Participants
|
6.0 YEARS
STANDARD_DEVIATION 1.00 • n=121 Participants
|
14.3 YEARS
STANDARD_DEVIATION 2.45 • n=24 Participants
|
10.1 YEARS
STANDARD_DEVIATION 2.97 • n=6 Participants
|
14.7 YEARS
STANDARD_DEVIATION 1.53 • n=33 Participants
|
12.9 YEARS
STANDARD_DEVIATION 3.50 • n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=37 Participants
|
7 Participants
n=44 Participants
|
5 Participants
n=40 Participants
|
3 Participants
n=121 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=33 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: DLT-evaluable population consists of participants in Part 1 who completed the DLT observation period through at least 2 cycles of study treatment (including ≥80% of the intended niraparib dose and ≥2 infusions of dostarlimab) or experienced a DLT.
DLT referred to adverse effects within the first 42 days of treatment, indicating the maximum tolerated dose. DLTs included treatment-related Grade (G) 4 non-haematologic AEs or G3 AEs unresolved to G≤1 within 48 hours. G3/4 non-haematologic lab abnormalities were DLTs if causing hospitalization or persisting ≥7 days with symptoms or requiring intervention. Haematologic DLTs included prolonged G4 thrombocytopenia, G3/4 thrombocytopenia with bleeding or transfusion needs, prolonged G4 neutropenia, G3/4 neutropenia with infection, and G3/4 anemia requiring transfusion. Other criteria included Cycle 2 delays \>2 weeks, unresolved G≥2 uveitis/endocrine toxicity, persistent colitis/diarrhea, unresolved G3/4 immune-related AEs, G≥3 infusion reactions, hemophagocytic lymphohistiocytosis, posterior reversible encephalopathy syndrome, and treatment-related G5 AE. DLT-evaluable participants completed ≥2 cycles with ≥80% of planned niraparib and ≥2 dostarlimab infusions or had a DLT.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=8 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=6 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=2 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=2 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants With Dose-limiting Toxicities (DLT)
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: DLT-evaluable Population consists of participants in Part 2 Safety Run-in who completed the DLT observation period through at least 2 cycles of study treatment (including ≥80% of the intended niraparib dose and ≥2 infusions of dostarlimab) or experienced a DLT.
DLT referred to adverse effects within the first 42 days of treatment, indicating the maximum tolerated dose. DLTs included treatment-related Grade (G) 4 non-haematologic AEs or G3 AEs unresolved to G≤1 within 48 hours. G3/4 non-haematologic lab abnormalities were DLTs if causing hospitalization or persisting ≥7 days with symptoms or requiring intervention. Haematologic DLTs included prolonged G4 thrombocytopenia, G3/4 thrombocytopenia with bleeding or transfusion needs, prolonged G4 neutropenia, G3/4 neutropenia with infection, and G3/4 anemia requiring transfusion. Other criteria included Cycle 2 delays \>2 weeks, unresolved G≥2 uveitis/endocrine toxicity, persistent colitis/diarrhea, unresolved G3/4 immune-related AEs, G≥3 infusion reactions, hemophagocytic lymphohistiocytosis, posterior reversible encephalopathy syndrome, and treatment-related G5 AE. DLT-evaluable participants completed ≥2 cycles with ≥80% of planned niraparib and ≥2 dostarlimab infusions or had a DLT.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Number of Participants With Dose-limiting Toxicities (DLT)
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: DLT-evaluable Population consists of participants in Part 2 Safety Run-in who completed the DLT observation period through at least 2 cycles of study treatment (including ≥80% of the intended niraparib dose and ≥2 infusions of dostarlimab) or experienced Grade ≥3 thrombocytopenia AEs.
Thrombocytopenia events were defined as treatment-related toxicities of Grade 3 or Grade 4 thrombocytopenia occurring within the first 42 days of study treatment. AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Number of Participants With Grade ≥3 Thrombocytopenia Adverse Events
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: Modified Intent-to-treat (mITT) population for Part 2A Osteosarcoma cohort included participants who received any study medication, had measurable baseline tumour assessment, and had at least 1 post-baseline tumour assessment. Data from 1 participant treated in Part 1A Cohort 1A at the same dose level as 8 participants treated in Part 2A were pooled and analyzed collectively for this outcome measure.
PFS6 is defined as the percentage of participants without progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death at 6 months from the date of the first dose of study treatment. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=9 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Progression-Free Survival at 6 Months Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2B Neuroblastoma cohort included participants who received any study medication, had measurable baseline tumour assessment and/or MIBG-positive disease (or FDG-positive disease, for MIBG-nonavid tumours) at baseline, and had at least 1 post-baseline tumour assessment. Data from 2 participants treated in Part 1A Cohort 1A at the same dose level as 6 participants treated in Part 2B were pooled and analyzed collectively for this outcome measure.
ORR is defined as the percentage of participants who have a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Investigator using International Neuroblastoma Response Criteria (INRC). CR is resolution of all detectable disease, including soft tissue, bone, and bone marrow, with residual lesion measurements \<10 mm and no tumor infiltration in the bone marrow or abnormal MIBG/FDG uptake. PR: Significant reduction in tumor burden, including a ≥30% decrease in primary or metastatic lesion size and ≥50% reduction in bone involvement (MIBG/FDG), with no new lesions and bone marrow infiltration ≤5%.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=8 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Objective Response Rate (ORR) by the Investigator Using International Neuroblastoma Response Criteria (INRC)
|
0 Percentage of Participants
Interval 0.0 to 36.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ITT Population included all participants who received any study medication and had measurable baseline tumour assessment and/or, for neuroblastoma participants, MIBG-positive disease (or FDG-positive disease, for MIBG-nonavid tumours) at baseline.
ORR is the percentage of participants with a best overall response (BOR) of confirmed CR or PR using RECIST v1.1 or INRC (for neuroblastoma participants only) as determined by the Investigator. Per RECIST v1.1: CR is disappearance of all target lesions, with pathological lymph nodes \<10 mm in short axis. PR is ≥30% decrease in sum of diameters of target lesions, referencing baseline sum (percent change from baseline). Per INRC: CR is resolution of all detectable disease, including soft tissue, bone, and bone marrow, with residual lesion measurements \<10 mm and no tumor infiltration in the bone marrow or abnormal MIBG/FDG uptake. PR: Significant reduction in tumor burden, including a ≥30% decrease in primary or metastatic lesion size and ≥50% reduction in bone involvement (MIBG/FDG), with no new lesions and bone marrow infiltration ≤5%.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=6 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Objective Response Rate (ORR)
|
9 Percentage of Participants
Interval 0.2 to 41.3
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ITT population. Only responders (CR or PR) by investigator assessment were included in this analysis.
DOR is the time from first documented response (CR or PR) to first PD by RECIST v1.1 or INRC (neuroblastoma only), based on Investigator assessment, or death (whichever occurs first). If no PD or death occurs post-response, participants are censored at their last tumor assessment date. Per RECIST v1.1, CR is disappearance of all target lesions; PR is ≥30% decrease in lesion diameters from baseline; PD is ≥20% increase in lesion sum from nadir plus ≥5 mm absolute increase. Per INRC, CR is resolution of detectable disease, including soft tissue, bone, and bone marrow, with residual lesions \<10 mm, no bone marrow infiltration, and normal MIBG/FDG uptake. PR is a ≥30% decrease in lesion size, ≥50% reduction in bone involvement (MIBG/FDG), no new lesions, and bone marrow infiltration ≤5%. PD is \>20% lesion size increase, new lesions, or increased infiltration in bone marrow.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=1 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Duration of Response (DOR)
|
37.29 Months
Full range is not applicable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population is defined as all participants who received at least 1 dose of either niraparib or dostarlimab.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
TEAEs
|
11 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Part 1A and Part 1B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
SAEs
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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 |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
TEAEs leading to Death
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A and Part 1B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Treatment Discontinuation
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2.5 hours (HR) and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2Population: Pharmacokinetic (PK) population included all participants who received at least one dose of study treatment and had at least one PK sample. Only those participants with data available at specified data points have been analyzed.
Blood samples were obtained to analyze niraparib concentration levels.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Niraparib Concentrations
Cycle 1 Week 2, 168 HR post-dose
|
419.255 nanogram/ millilitre (ng/mL)
Standard Deviation 203.6362
|
396.286 nanogram/ millilitre (ng/mL)
Standard Deviation 276.8006
|
812.000 nanogram/ millilitre (ng/mL)
Standard Deviation 704.5534
|
887.667 nanogram/ millilitre (ng/mL)
Standard Deviation 628.3664
|
|
Part 1A and Part 1B: Niraparib Concentrations
Cycle 1 Week 1, 2.5 HR post-dose
|
120.045 nanogram/ millilitre (ng/mL)
Standard Deviation 198.6774
|
44.300 nanogram/ millilitre (ng/mL)
Standard Deviation 58.0753
|
83.480 nanogram/ millilitre (ng/mL)
Standard Deviation 107.4614
|
383.900 nanogram/ millilitre (ng/mL)
Standard Deviation 413.0918
|
|
Part 1A and Part 1B: Niraparib Concentrations
Cycle 1 Week 1, 7 HR post-dose
|
347.889 nanogram/ millilitre (ng/mL)
Standard Deviation 133.9846
|
254.571 nanogram/ millilitre (ng/mL)
Standard Deviation 141.7096
|
640.200 nanogram/ millilitre (ng/mL)
Standard Deviation 449.5850
|
522.500 nanogram/ millilitre (ng/mL)
Standard Deviation 369.8168
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1; 1 HR post-dose on Cycle 1 Week 1; 168 HR post-dose on Cycle 1 Week 2; 504 HR post-dose) on Cycle 2 Week 1; Pre-dose on Week 1 of Cycles 4, 6, 12, 18, 24, 30, 36; End of Treatment (Up to approximately 196 weeks)Population: PK population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point. Rows and Arms/Groups with 0 participants analyzed represent time points at which no participant data was available from within the respective Arms/Groups.
Blood samples were collected for PK analysis of Dostarlimab.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 4 Week 1, Pre-dose
|
23.100 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
81.400 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 6 Week 1, Pre-dose
|
25.100 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
103.000 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 12 Week 1, Pre-dose
|
21.400 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
58.400 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 36 Week 1, Pre-dose
|
33.500 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
End of Treatment, End of Treatment
|
16.543 milligram/ litre (mg/L)
Standard Deviation 8.6016
|
58.700 milligram/ litre (mg/L)
Standard Deviation 47.2811
|
16.507 milligram/ litre (mg/L)
Standard Deviation 13.6358
|
46.800 milligram/ litre (mg/L)
Standard Deviation 40.5879
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 1 Week 1, Day 1 pre-dose
|
0.000 milligram/ litre (mg/L)
Standard Deviation 0.0000
|
0.000 milligram/ litre (mg/L)
Standard Deviation 0.0000
|
0.000 milligram/ litre (mg/L)
Standard Deviation 0.0000
|
0.000 milligram/ litre (mg/L)
Standard Deviation 0.0000
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 1 Week 1, 1 hr post-dose
|
58.291 milligram/ litre (mg/L)
Standard Deviation 10.7135
|
124.743 milligram/ litre (mg/L)
Standard Deviation 30.9267
|
69.720 milligram/ litre (mg/L)
Standard Deviation 9.8228
|
129.000 milligram/ litre (mg/L)
Standard Deviation 2.6458
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 1 Week 2, 168 hrs post-dose
|
21.045 milligram/ litre (mg/L)
Standard Deviation 4.5276
|
55.314 milligram/ litre (mg/L)
Standard Deviation 10.1568
|
28.660 milligram/ litre (mg/L)
Standard Deviation 14.1661
|
55.600 milligram/ litre (mg/L)
Standard Deviation 8.2286
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 18 Week 1, Pre-dose
|
21.200 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
60.900 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 24 Week 1, Pre-dose
|
12.400 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 30 Week 1, Pre-dose
|
33.800 milligram/ litre (mg/L)
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1A and Part 1B: Dostarlimab Concentrations
Cycle 2 Week 1, 504 hrs post-dose
|
12.256 milligram/ litre (mg/L)
Standard Deviation 2.1518
|
35.100 milligram/ litre (mg/L)
Standard Deviation 11.1095
|
13.240 milligram/ litre (mg/L)
Standard Deviation 5.0411
|
43.000 milligram/ litre (mg/L)
Standard Deviation 7.4953
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Immunogenicity (ADA) Population included all participants who received at least 1 dose of dostarlimab and who had at least 1 ADA sample with a result.
Blood samples were collected for the analysis of the presence of ADAs using electrochemiluminescence. All samples were tested in screening and confirmatory assay, and positive samples were further characterized for antibody titers.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 1 of Cycle 1Population: Safety Population
The acceptability and palatability for participants who received niraparib tablet or TfOS were evaluated by using a questionnaire.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 Participants
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 1A and Part 1B: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires
|
11 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Intent-to-treat population included all participants who received any study medication and had measurable baseline tumour assessment.
ORR is the percentage of participants with a best overall response (BOR) of confirmed CR or PR, using RECIST v1.1 or INRC (neuroblastoma only) as determined by the Investigator. Per RECIST v1.1: CR is disappearance of all target lesions, with pathological lymph nodes \<10 mm in short axis. PR is ≥30% decrease in sum of diameters of target lesions, referencing baseline sum (percent change from baseline). Per INRC: CR is resolution of all detectable disease, including soft tissue, bone, and bone marrow, with residual lesion measurements \<10 mm and no tumor infiltration in the bone marrow or abnormal MIBG/FDG uptake. PR: Significant reduction in tumor burden, including a ≥30% decrease in primary or metastatic lesion size and ≥50% reduction in bone involvement (MIBG/FDG), with no new lesions and bone marrow infiltration ≤5%.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Objective Response Rate (ORR)
|
0 Percentage of Participants
No participants achieved confirmed CR or PR
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ITT population. Only responders (CR or PR) by investigator assessment were included in this analysis.
DOR is the time from first documented response (CR or PR) to first PD by RECIST v1.1 or INRC (neuroblastoma only), based on Investigator assessment, or death (whichever occurs first). It is calculated for participants with a BOR of confirmed CR or PR. If no PD or death occurs post-response, participants are censored at their last tumor assessment date. Per RECIST v1.1, CR is disappearance of all target lesions; PR is ≥30% decrease in lesion diameters from baseline; PD is ≥20% increase in lesion sum from nadir plus ≥5 mm absolute increase. Per INRC, CR is resolution of detectable disease, including soft tissue, bone, and bone marrow, with residual lesions \<10 mm, no bone marrow infiltration, and normal MIBG/FDG uptake. PR is a ≥30% decrease in lesion size, ≥50% reduction in bone involvement (MIBG/FDG), no new lesions, and bone marrow infiltration ≤5%. PD is \>20% lesion size increase, new lesions, or increased infiltration in bone marrow.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ITT population
DCR is the percentage of participants achieving a BOR of confirmed CR, PR, or stable disease (SD) by RECIST v1.1 or INRC (neuroblastoma only). Per RECIST v1.1: CR is disappearance of all target lesions and pathological lymph nodes \<10 mm in short axis; PR is ≥30% decrease in lesion diameters from baseline; SD is neither sufficient shrinkage for PR nor sufficient increase for PD. Per INRC: CR is resolution of all detectable disease (soft tissue, bone, marrow) with residual lesion \<10 mm, no tumor infiltration in the bone marrow, and no abnormal MIBG or FDG/PET uptake. PR is ≥30% decrease in lesion size, ≥50% bone involvement reduction (MIBG/FDG uptake), no new lesions, and bone marrow infiltration ≤5%. SD was defined as neither sufficient shrinkage for PR nor sufficient increase for PD at the primary site. Bone marrow infiltration remains \>5%.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Disease Control Rate (DCR)
|
0 Percentage of Participants
No participants with confirmed CR, PR or stable disease
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ITT population
PFS is defined as the time from the date of the first dose of study treatment to the first documented PD, as determined by RECIST v1.1 or INRC (in participants with neuroblastoma only) based on Investigator assessment, or death from any cause (whichever occurs first). Per RECISTv1.1: PD was defined as At least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Per INRC: PD is \>20% lesion size increase, new lesions, or increased marrow tumor infiltration (\>5%).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Progression-free Survival (PFS)
|
1.68 Months
Interval 1.35 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
TEAEs
|
3 Participants
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
SAEs
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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 |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Leading to Death
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Treatment Discontinuation
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2.5 HR and 7 HR post-dose on Cycle 1 Week 1, Pre-dose on Cycle 1 Week 2 and Pre-dose and 5 HR post-dose on Cycle 2 Week 1Population: PK population. Only those participants with data available at specified data points have been analyzed.
Blood samples were obtained to analyze niraparib concentration levels.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=3 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2 Safety-run in: Niraparib Concentrations
Cycle 1 Week 1, 2.5 HR post-dose
|
109.000 ng/mL
Standard Deviation 121.7060
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Niraparib Concentrations
Cycle 1 Week 1, 7 HR post-dose
|
292.067 ng/mL
Standard Deviation 225.1404
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Niraparib Concentrations
Cycle 1 Week 2, Pre-dose
|
329.200 ng/mL
Standard Deviation 272.7140
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Niraparib Concentrations
Cycle 2 Week 1, Pre-dose
|
338.667 ng/mL
Standard Deviation 253.1291
|
—
|
—
|
—
|
|
Part 2 Safety-run in: Niraparib Concentrations
Cycle 2 Week 1, 5 HR post-dose
|
834.667 ng/mL
Standard Deviation 612.8428
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Osteosarcoma cohort. Only those participants at specified timepoint have been anaysed. Data from 1 participant treated in Part 1A Cohort 1A at the same dose level as 8 participants treated in Part 2A were pooled and analyzed collectively for this outcome measure.
ORR is defined as the percentage of participants who have a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1. CR was defined as disappearance of all target and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=9 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Objective Response Rate (ORR) by the Investigator Using RECIST v1.1
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Osteosarcoma cohort. Only responders (CR or PR) by investigator assessment were included in this analysis.
DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by RECIST v1.1 , based on Investigator assessment, or death (whichever occurs first). CR was defined as disappearance of all target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). PD was defined as At least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2A Osteosarcoma cohort. Data from 1 participant treated in Part 1A Cohort 1A at the same dose level as 8 participants treated in Part 2A were pooled and analyzed collectively for this outcome measure.
DCR is defined as the percentage of participants who have achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) by RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=9 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Disease Control Rate (DCR) by the Investigator Using RECIST v1.1
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2A Osteosarcoma cohort. Data from 1 participant treated in Part 1A Cohort 1A at the same dose level as 8 participants treated in Part 2A were pooled and analyzed collectively for this outcome measure.
PFS is defined as the time from the date of the first dose of study treatment to the first documented PD, as determined by RECIST v1.1 , based on Investigator assessment, or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=9 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Progression-free Survival (PFS) by the Investigator Using RECIST v1.1
|
1.2 Months
Interval 0.7 to 2.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Number of Participants With of Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
SAEs
|
4 Participants
|
—
|
—
|
—
|
|
Part 2A: Number of Participants With of Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
TEAEs
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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 |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Leading to Death
|
0 Participants
|
—
|
—
|
—
|
|
Part 2A: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Treatment Discontinuation
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2.5 HR and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2Population: PK population. Only those participants with data available at specified data points have been analyzed.
Blood samples were obtained to analyze niraparib concentration levels.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Niraparib Concentrations
Cycle 1 Week 1, 2.5 HR post-dose
|
217.212 ng/mL
Standard Deviation 236.5667
|
—
|
—
|
—
|
|
Part 2A: Niraparib Concentrations
Cycle 1 Week 1, 7 HR post-dose
|
241.482 ng/mL
Standard Deviation 143.3515
|
—
|
—
|
—
|
|
Part 2A: Niraparib Concentrations
Cycle 1 Week 2, 168 HR post-dose
|
354.100 ng/mL
Standard Deviation 153.7909
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1; 1 HR post-dose on Cycle 1 Week 1; 168 HR post-dose on Cycle 1 Week 2; 504 HR post-dose) on Cycle 2 Week 1; Pre-dose on Week 1 of Cycles 4 and 6; End of Treatment (Up to approximately 196 weeks)Population: PK population. Only those participants with data available at specified data points have been analyzed.
Blood samples were collected for PK analysis of Dostarlimab.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Dostarlimab Concentrations
Cycle 1 Week 1, Day 1 pre-dose
|
0.000 mg/L
Standard Deviation 0.0000
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
Cycle 1 Week 1, 1 hr post-dose
|
135.509 mg/L
Standard Deviation 45.2007
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
Cycle 1 Week 2, 168 hrs post-dose
|
65.022 mg/L
Standard Deviation 8.6129
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
Cycle 2 Week 1, 504 hrs post-dose
|
45.000 mg/L
Standard Deviation 27.4571
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
Cycle 4 Week 1, Pre-dose
|
46.900 mg/L
Standard Deviation 23.0517
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
Cycle 6 Week 1, Pre-dose
|
133.000 mg/L
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Dostarlimab Concentrations
End of Treatment, End of Treatment
|
74.338 mg/L
Standard Deviation 52.2281
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ADA Population
Blood samples were collected for the analysis of the presence of ADAs using electrochemiluminescence. All samples were tested in screening and confirmatory assay, and positive samples were further characterized for antibody titers.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=10 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 1 of Cycle 1Population: Safety Population
The acceptability and palatability for participants who received niraparib tablet were evaluated by using a questionnaire.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2A: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2B Neuroblastoma cohort. Only responders (CR or PR) by investigator assessment were included in this analysis.
DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by INRC , based on Investigator assessment, or death (whichever occurs first). CR is resolution of all detectable disease, including soft tissue, bone, and bone marrow, with residual lesion measurements \<10 mm and no tumor infiltration in the bone marrow or abnormal MIBG/FDG uptake. PR: Significant reduction in tumor burden, including a ≥30% decrease in primary or metastatic lesion size and ≥50% reduction in bone involvement (MIBG/FDG), with no new lesions and bone marrow infiltration ≤5%. PD is \>20% lesion size increase,new lesions or increased tumor infiltration in bone marrow.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2B Neuroblastoma cohort. Data from 2 participants treated in Part 1A Cohort 1A at the same dose level as 6 participants treated in Part 2B were pooled and analyzed collectively for this outcome measure.
DCR is defined as the percentage of participants who have achieved a BOR of confirmed CR, confirmed PR, or SD by INRC. CR is resolution of all detectable disease (soft tissue, bone, marrow) with residual lesion \<10 mm, no tumor infiltration in the bone marrow, and no abnormal MIBG or FDG/PET uptake. PR is ≥30% decrease in lesion size, ≥50% bone involvement reduction (MIBG/FDG uptake), no new lesions, and bone marrow infiltration ≤5%. SD was defined as neither sufficient shrinkage for PR nor sufficient increase for PD at the primary site. Bone marrow infiltration remains \>5%.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=8 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Disease Control Rate (DCR) by the Investigator by INRC
|
38 Percentage of Participants
Interval 8.5 to 75.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Modified Intent-to-treat (mITT) population for Part 2B Neuroblastoma cohort. Data from 2 participants treated in Part 1A Cohort 1A at the same dose level as 6 participants treated in Part 2B were pooled and analyzed collectively for this outcome measure.
PFS is defined as the time from the date of the first dose of study treatment to the first documented PD, as determined by INRC , based on Investigator assessment, or death (whichever occurs first). PD is \>20% lesion size increase, new lesions, or increased tumor infiltration in bone marrow.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=8 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Progression-free Survival (PFS) by the Investigator by INRC
|
2.9 Months
Interval 0.5 to 10.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is any event that emerged during treatment and 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. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
TEAEs
|
7 Participants
|
—
|
—
|
—
|
|
Part 2B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
SAEs
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety population
Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: Safety Population
A TEAE is any event that emerged during treatment and 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 |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Leading to Death
|
0 Participants
|
—
|
—
|
—
|
|
Part 2B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation
Treatment Discontinuation
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2.5 HR and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2Population: PK population. Only those participants with data available at specified data points have been analyzed.
Blood samples were obtained to analyze niraparib concentration levels.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Niraparib Concentrations
Cycle 1 Week 1, 7 HR post-dose
|
329.571 ng/mL
Standard Deviation 182.8432
|
—
|
—
|
—
|
|
Part 2B: Niraparib Concentrations
Cycle 1 Week 2, 168 HR post-dose
|
700.143 ng/mL
Standard Deviation 571.6900
|
—
|
—
|
—
|
|
Part 2B: Niraparib Concentrations
Cycle 1 Week 1, 2.5 HR post-dose
|
275.600 ng/mL
Standard Deviation 330.9424
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1; 1 HR post-dose on Cycle 1 Week 1; 168 HR post-dose on Cycle 1 Week 2; 504 HR post-dose on Cycle 2 Week 1; Pre-dose on Week 1 of Cycles 4, 6, 12 and 18; End of Treatment (Up to approximately 196 weeks)Population: PK population. Only those participants with data available at specified data points have been analyzed.
Blood samples were collected for PK analysis of Dostarlimab.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Dostarlimab Concentrations
Cycle 1 Week 1, Day 1 pre-dose
|
0.000 mg/L
Standard Deviation 0.0000
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 1 Week 1, 1 hr post-dose
|
186.000 mg/L
Standard Deviation 117.4748
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 1 Week 2, 168 hrs post-dose
|
61.943 mg/L
Standard Deviation 13.5405
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 2 Week 1, 504 hrs post-dose
|
39.925 mg/L
Standard Deviation 13.4205
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 4 Week 1, Pre-dose
|
88.500 mg/L
Standard Deviation 22.3900
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 6 Week 1, Pre-dose
|
173.667 mg/L
Standard Deviation 90.4231
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 12 Week 1, Pre-dose
|
179.500 mg/L
Standard Deviation 24.7487
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
Cycle 18 Week 1, Pre-dose
|
121.000 mg/L
Standard Deviation NA
Standard deviation is not evaluable as only single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2B: Dostarlimab Concentrations
End of Treatment, End of Treatment
|
93.580 mg/L
Standard Deviation 69.6794
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 196 weeksPopulation: ADA Population
Blood samples were collected for the analysis of the presence of ADAs using electrochemiluminescence. All samples were tested in screening and confirmatory assay, and positive samples were further characterized for antibody titers.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 1 of Cycle 1Population: Safety Population
The acceptability and palatability for participants who received niraparib tablet were evaluated by using a questionnaire.
Outcome measures
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=7 Participants
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
|---|---|---|---|---|
|
Part 2B: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires
|
7 Participants
|
—
|
—
|
—
|
Adverse Events
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
Serious adverse events
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 participants at risk
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
n=11 participants at risk
Paediatric participants with recurrent or refractory osteosarcoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
n=7 participants at risk
Paediatric participants with recurrent or refractory neuroblastoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
n=3 participants at risk
Paediatric participants with recurrent or refractory osteosarcoma or neuroblastoma received niraparib (dose based on weight) tablet for oral suspension (TfOS) orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Chest pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
Other adverse events
| Measure |
Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)
n=11 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, disease progression (PD), unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg
n=7 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1A Cohort 1B: Niraparib 200 mg + Dostarlimab 3 mg/kg
n=5 participants at risk
Paediatric participants with recurrent or refractory solid tumours received 200 mg niraparib tablet orally once daily along with 3 mg/kg dostarlimab solution as a 30-minute IV infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 1B Cohort 1: Niraparib AAOLF (Age-based Dose) + Dostarlimab 7.5 mg/kg
n=3 participants at risk
Paediatric participants with recurrent or refractory solid tumours received niraparib (dose based on age) age-appropriate liquid formulation (AAOLF) orally once daily and 7.5 mg/kg dostarlimab as a 30-minute IV infusion before the niraparib dose on Day 1 of each 21-day cycle until the end of the Treatment Period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision, or death.
|
Part 2A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Osteosarcoma)
n=11 participants at risk
Paediatric participants with recurrent or refractory osteosarcoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2B: Niraparib 100 mg + Dostarlimab 7.5 mg/kg (Neuroblastoma)
n=7 participants at risk
Paediatric participants with recurrent or refractory neuroblastoma received 100 mg niraparib tablet orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
Part 2: Safety- Run-In Niraparib TfOS (Weight-based Dose) + Dostarlimab 7.5 mg/kg
n=3 participants at risk
Paediatric participants with recurrent or refractory osteosarcoma or neuroblastoma received niraparib (dose based on weight) tablet for oral suspension (TfOS) orally once daily along with 7.5 mg/kg dostarlimab solution as a 30-minute intravenous (IV) infusion prior to the niraparib dose on Day 1 of each 21-day treatment cycle until the end of treatment period, PD, unacceptable toxicity, withdrawal of consent/assent, investigator's decision to withdraw, or death.
|
|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Anaemia
|
63.6%
7/11 • Number of events 12 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 8 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
100.0%
3/3 • Number of events 6 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
27.3%
3/11 • Number of events 9 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 8 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
100.0%
3/3 • Number of events 8 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
2/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 6 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 9 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Cardiac disorders
Tachycardia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Eye disorders
Dry eye
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Eye disorders
Eyelid ptosis
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
60.0%
3/5 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
60.0%
3/5 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
57.1%
4/7 • Number of events 7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Asthenia
|
27.3%
3/11 • Number of events 7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Fatigue
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Hyperthermia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Localised oedema
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Pyrexia
|
63.6%
7/11 • Number of events 13 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Swelling
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
General disorders
Systemic inflammatory response syndrome
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Gingivitis
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
57.1%
4/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Amylase increased
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood creatinine increased
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Blood urea increased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
C-reactive protein increased
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Lipase increased
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Platelet count decreased
|
18.2%
2/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
66.7%
2/3 • Number of events 8 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Protein urine present
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Tri-iodothyronine increased
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
Weight decreased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
2/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
42.9%
3/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
40.0%
2/5 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Number of events 7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
2/11 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
20.0%
1/5 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/5 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/3 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
33.3%
1/3 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected upto approximately 196 weeks.
The Safety Population included all participants who received at least 1 dose of either niraparib or dostarlimab.
|
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