Dose Escalation and Cohort Expansion Study of Niraparib a... | NCT04544995

ID	Type	Description	Link
2020-002359-39	EudraCT Number

Label	Type	Description	Intervention Names
Part 1A: Dose Escalation	Experimental	Participants with body weight of ≥ 20 kilogram (kg) and who can swallow niraparib tablets will receive niraparib tablets and dostarlimab.	Drug: Dostarlimab Drug: Niraparib (Tablet)
Part 1B: Dose Escalation	Experimental	Participants who are <8 years of age will receive niraparib TfOS and dostarlimab.	Drug: Niraparib (Tablet for oral suspension) Drug: Dostarlimab
Part 2 Safety Run-in	Experimental	Participants with osteosarcoma or neuroblastoma who are ≥8 years of age will receive niraparib TfOS and dostarlimab.	Drug: Niraparib (Tablet for oral suspension) Drug: Dostarlimab
Part 2A: Cohort Expansion for Osteosarcoma	Experimental	Participants with osteosarcoma will receive the RP2D of the combination of niraparib and dostarlimab.	Drug: Niraparib (Tablet for oral suspension) Drug: Dostarlimab Drug: Niraparib (Tablet)
Part 2B: Cohort Expansion for Neuroblastoma	Experimental	Participants with neuroblastoma will receive the RP2D of the combination of niraparib and dostarlimab.

Name	Type	Description	Arm Group Labels	Other Names
Niraparib (Tablet for oral suspension)	Drug	Niraparib will be administered as TfOS (Tablet for oral suspension)	Part 1B: Dose Escalation Part 2 Safety Run-in

Measure	Description	Time Frame
Part 1A and Part 1B: Number of Participants With Dose-limiting Toxicities (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.	Up to 42 days
Part 2 Safety-run in: Number of Participants With Dose-limiting Toxicities (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.	Up to 42 days
Part 2 Safety-run in: Number of Participants With Grade ≥3 Thrombocytopenia Adverse Events	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.

Measure	Description	Time Frame
Part 1A and Part 1B: Objective Response Rate (ORR)	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%.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For Part 1 and Part 2:

Participant is a child or an adolescent greater than or equal to (>=) 6 months to less than (<) 18 years old at the time of informed consent/assent.
Participant with disease other than neuroblastoma has radiologically measurable disease at screening that can be tracked as RECIST v1.1 target lesion(s).
Participant with neuroblastoma has measurable/evaluable target and/or non-target disease by INRC at screening. Neuroblastoma participants with recurrent/relapsed bone metastasis that is metaiodobenzylguanidine (MIBG)-positive (or FDG-PET positive, for MIBG-nonavid tumors) as only site of disease are eligible.
Performance status must be >=60 percent on the Karnofsky scale for participants >16 years of age and >=60 percent on the Lansky scale for participants less than or equal to (<=) 16 years of age.
Participant has adequate organ function.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective.
A male participant of reproductive potential is eligible to participate if he agrees to refrain from donating sperm plus, either be abstinent from heterosexual intercourse or must agree to use a male condom starting with the first dose of study treatment through at least 90 days after the last dose of study treatment.

For Part 1 only:

• Participant has recurrent or refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma, rhabdomyosarcoma, or any other solid tumor (excluding tumors of the central nervous system [CNS]) and must not be eligible for alternative curative treatment: i. Participants with non-CNS solid tumours other than osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma or rhabdomyosarcoma are required to have prior documented breast cancer susceptibility gene (BRCAness) mutational signature (mutational signature 3) on deoxyribonucleic acid (DNA) sequencing of tumor obtained in the relapsed/recurrent disease setting, within 6 (preferably 3) months of Cycle 1 Day 1.

ii. For participants with documented BRCAness mutational signature: Existing information on molecular profiling of the participant's tumor tissue must be through a molecular profiling platform such as Individualized Therapy for Relapsed Malignancies in Childhood (INFORM). Molecular profile information must contain information from whole exome sequencing or whole genome sequencing, including the mutation status of BRCA1 and BRCA 2 and other homologous recombination DNA repair (HRR) pathway genes, mutational signatures including mutational signature 3, and tumor mutational burden (TMB).

iii. NOTE: Participants with recurrent or refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma, or rhabdomyosarcoma are asked to provide documentation, if available, of the BRCAness mutational signature analysis on DNA sequencing of their tumour.

For Part 2A:

• Participant has recurrent or refractory osteosarcoma and must not be eligible for alternative curative treatment.

Documentation of BRCAness mutational signature 3 will be requested, but not required, for enrollment.

• Participant must confirm at screening that an archival or fresh tumor tissue sample is available for use, in retrospective exploratory biomarker analysis. Otherwise, enrolling site must discuss with Sponsor.

For Part 2B:

Participant has recurrent or refractory neuroblastoma and must not be eligible for alternative curative treatment. Documentation of BRCAness mutational signature 3 will be requested, but not required, for enrollment.
Participant must confirm at screening that an archival or fresh tumor tissue sample is available for use, in retrospective exploratory biomarker analysis. Otherwise, enrolling site must discuss with Sponsor.

Exclusion Criteria:

For Part 1 and Part 2:

Participant has known hypersensitivity to dostarlimab or niraparib, their components, or their excipients.
Participant has a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Participant has active autoimmune disease that has required systemic treatment in the past 2 years (that is [i.e.], with use of disease-modifying anti-rheumatic drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (for example [e.g.], thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Participant has known active CNS metastases, carcinomatous meningitis, or both. Carcinomatous meningitis precludes a participant from study participation regardless of clinical stability.
Participant had a known additional (second primary) malignancy that progressed or required active treatment within the last 2 years.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection that requires systemic therapy.
Participant has a condition (such as transfusion-dependent anemia or thrombocytopenia), requirement for therapy, or laboratory abnormality that might confound the study results or interfere with the participant's participation for the full duration of the study treatment.
Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Participant has a known history of human immunodeficiency virus (HIV) (type 1 or 2 antibodies).
Participant has documented presence of HbsAg and/or HBcAb at Screening or within 3 months prior to first dose of study intervention. Participants with a negative HbsAg and positive HbcAb result are eligible only if HBV DNA is negative.
Participant must not have a gastrointestinal condition, such as bowel obstruction, that can impact absorption of oral medications and is identified by clinical symptoms or CT scan, etc.
Participant has had any known Grade 3 or 4 anemia, neutropenia, and/or thrombocytopenia that was related to the most recent prior anti-cancer treatment and that persisted >4 weeks (28 days).
Participant has not recovered (i.e., to Grade ≤1 or to baseline) from prior systemic anticancer therapy-induced AEs. Note: Participants with alopecia, hearing impairment, Grade ≤2 neuropathy, Grade ≤2 fatigue, Grade ≤ 2 anaemia, and/or Grade ≤2 neutropenia are an exception to this criterion and may qualify for participation in the study.
Participant had toxicity related to prior immunotherapy that led to study treatment discontinuation.
Participant had treatment with systemic anticancer therapy (investigational agent or device, or approved chemotherapy, targeted therapy, immunotherapy, or other systemic therapy) within 3 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, radiation therapy encompassing >20 percent of the bone marrow within 2 weeks prior to the first dose of study treatment, or any radiation therapy within 1 week prior to the first dose of study treatment.
Participant has not recovered adequately from AEs or complications from any major surgery prior to starting study treatment.
Participant has received a live vaccine within 30 days of planned start of study treatment.
Participant has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, and history of cerebrovascular accident) within 6 months of enrolment.
Participant has heart rate-corrected QT interval prolongation at screening >450 milliseconds (msec) or >480 msec for participants with bundle branch block.
Participant has received a solid organ transplant.
Participant has a documented presence of HCV antibody at Screening or within 3 months prior to first dose of study intervention. NOTE: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, if a confirmatory HCV RNA test is negative and the participant otherwise meets entry criteria.
Participant has a documented presence of HCV RNA at Screening or within 3 months prior to first dose of study intervention. NOTE: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well.

For Part 2:

Participant has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1, anti-programmed cell death-ligand 2, anti-cytotoxic T-lymphocyte-associated antigen-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (with the exception of participants rolling over from Part 1 of the study: these participants are allowed to have received dostarlimab).
Participant has had prior treatment with a known poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor (with the exception of participants rolling over from Part 1 of the study: these participants are allowed to have received niraparib).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham		B4 6NH	United Kingdom
GSK Investigational Site

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 17, 2024	Sep 30, 2025

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Anticipated Posting Date

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Analyses

Primary

Part 1A and Part 1B: Number of Participants With Dose-limiting Toxicities (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.

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.

Posted

Count of Participants

Participants

Up to 42 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG0008 OG0016 OG0022 OG003

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	OG0001 OG0011 OG0022 OG003

Primary

Part 2 Safety-run in: Number of Participants With Dose-limiting Toxicities (DLT)

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.

Posted

Count of Participants

Participants

Up to 42 days

ID	Title	Description
OG000	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.

Primary

Part 2 Safety-run in: Number of Participants With Grade ≥3 Thrombocytopenia Adverse Events

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.

Posted

Count of Participants

Participants

Up to 42 days

ID	Title	Description
OG000	Part 2: Safety- Run-In Niraparib TfOS (Weight- Based Dose) + Dostarlima b 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.

Units	Counts
Participants

Primary

Part 2A: Progression-Free Survival at 6 Months Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

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).

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

At Month 6

ID	Title	Description
OG000	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.

Primary

Part 2B: Objective Response Rate (ORR) by the Investigator Using International Neuroblastoma Response Criteria (INRC)

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%.

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 1A and Part 1B: Objective Response Rate (ORR)

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%.

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 1A and Part 1B: Duration of Response (DOR)

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.

ITT population. Only responders (CR or PR) by investigator assessment were included in this analysis.

Posted

Median

Full Range

Months

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 1A and Part 1B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

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).

Safety Population is defined as all participants who received at least 1 dose of either niraparib or dostarlimab.

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 1A and Part 1B: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)

Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Part 1A and Part 1B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Part 1A and Part 1B: Niraparib Concentrations

Blood samples were obtained to analyze niraparib concentration levels.

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.

Posted

Mean

Standard Deviation

nanogram/ millilitre (ng/mL)

2.5 hours (HR) and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Part 1A and Part 1B: Dostarlimab Concentrations

Blood samples were collected for PK analysis of Dostarlimab.

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.

Posted

Mean

Standard Deviation

milligram/ litre (mg/L)

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)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Part 1A and Part 1B: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab

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.

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.

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Part 1A and Part 1B: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires

The acceptability and palatability for participants who received niraparib tablet or TfOS were evaluated by using a questionnaire.

Safety Population

Posted

Count of Participants

Participants

At Week 1 of Cycle 1

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Part 2 Safety-run in: Objective Response Rate (ORR)

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%.

Intent-to-treat population included all participants who received any study medication and had measurable baseline tumour assessment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2 Safety-run in: Duration of Response (DOR)

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.

ITT population. Only responders (CR or PR) by investigator assessment were included in this analysis.

Posted

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2 Safety-run in: Disease Control Rate (DCR)

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%.

ITT population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2 Safety-run in: Progression-free Survival (PFS)

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%).

ITT population

Posted

Median

Full Range

Months

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2 Safety-run in: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2 Safety-run in: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)

Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2 Safety-run in: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Part 2 Safety-run in: Niraparib Concentrations

Blood samples were obtained to analyze niraparib concentration levels.

PK population. Only those participants with data available at specified data points have been analyzed.

Posted

Mean

Standard Deviation

ng/mL

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 1

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Objective Response Rate (ORR) by the Investigator Using RECIST v1.1

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).

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2A: Duration of Response (DOR) by the Investigator Using RECIST v1.1

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.

Modified Intent-to-treat (mITT) population for Osteosarcoma cohort. Only responders (CR or PR) by investigator assessment were included in this analysis.

Posted

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2A: Disease Control Rate (DCR) by the Investigator Using RECIST v1.1

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.

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2A: Progression-free Survival (PFS) by the Investigator Using RECIST v1.1

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).

Posted

Median

95% Confidence Interval

Months

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts

Secondary

Part 2A: Number of Participants With of Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2A: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)

Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Niraparib Concentrations

Blood samples were obtained to analyze niraparib concentration levels.

PK population. Only those participants with data available at specified data points have been analyzed.

Posted

Mean

Standard Deviation

ng/mL

2.5 HR and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Dostarlimab Concentrations

Blood samples were collected for PK analysis of Dostarlimab.

PK population. Only those participants with data available at specified data points have been analyzed.

Posted

Mean

Standard Deviation

mg/L

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)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab

ADA Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2A: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires

The acceptability and palatability for participants who received niraparib tablet were evaluated by using a questionnaire.

Safety Population

Posted

Count of Participants

Participants

At Week 1 of Cycle 1

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Duration of Response (DOR) by the Investigator by INRC

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.

Modified Intent-to-treat (mITT) population for Part 2B Neuroblastoma cohort. Only responders (CR or PR) by investigator assessment were included in this analysis.

Posted

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units

Secondary

Part 2B: Disease Control Rate (DCR) by the Investigator by INRC

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%.

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2B: Progression-free Survival (PFS) by the Investigator by INRC

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.

Posted

Median

95% Confidence Interval

Months

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Part 2B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

Safety population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Secondary

Part 2B: Number of Participants With Dostarlimab-Related Immune-Mediated Adverse Events (imAEs)

Dostarlimab-Related Immune-Mediated AEs were reported. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Safety population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

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.

Safety Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Niraparib Concentrations

Blood samples were obtained to analyze niraparib concentration levels.

PK population. Only those participants with data available at specified data points have been analyzed.

Posted

Mean

Standard Deviation

ng/mL

2.5 HR and 7 HR post-dose on Cycle 1 Week 1, 168 HR post-dose on Cycle 1 Week 2

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Dostarlimab Concentrations

Blood samples were collected for PK analysis of Dostarlimab.

PK population. Only those participants with data available at specified data points have been analyzed.

Posted

Mean

Standard Deviation

mg/L

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)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Number of Participants With Positive Anti-Drug Antibody (ADAs) to Dostarlimab

ADA Population

Posted

Count of Participants

Participants

Up to approximately 196 weeks

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Part 2B: Number of Participants Answered Acceptability and Palatability of Niraparib Via Questionnaires

The acceptability and palatability for participants who received niraparib tablet were evaluated by using a questionnaire.

Safety Population

Posted

Count of Participants

Participants

At Week 1 of Cycle 1

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG0030 events0 affected3 at risk EG0040 events0 affected11 at risk EG0053 events1 affected7 at risk EG0060 events0 affected3 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypotonia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Immune-mediated encephalitis	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Lethargy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Syncope	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00012 events7 affected11 at risk EG0015 events3 affected7 at risk EG0028 events2 affected5 at risk EG0036 events3 affected3 at risk EG0049 events3 affected11 at risk EG0058 events3 affected7 at risk EG0063 events2 affected3 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0014 events2 affected7 at risk EG0024 events2 affected5 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected7 at risk EG0025 events1 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0021 events1 affected5 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected11 at risk EG0010 events0 affected7 at risk EG0026 events2 affected5 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Dry eye	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Eye pruritus	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Swelling of eyelid	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Vision blurred	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected11 at risk EG0014 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected11 at risk EG0014 events2 affected7 at risk EG0023 events3 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0015 events2 affected7 at risk EG0024 events3 affected5 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected11 at risk EG0017 events4 affected7 at risk EG0023 events2 affected5 at risk EG003
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0007 events3 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0014 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Hyperthermia	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Localised oedema	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG00013 events7 affected11 at risk EG0011 events1 affected7 at risk EG0021 events1 affected5 at risk EG003
Swelling	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Gingivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Herpes dermatitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0013 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Herpes simplex reactivation	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Oral herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0015 events4 affected7 at risk EG0021 events1 affected5 at risk EG003
Amylase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0015 events3 affected7 at risk EG0021 events1 affected5 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Blood urea increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
C-reactive protein increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected11 at risk EG0013 events1 affected7 at risk EG0022 events1 affected5 at risk EG003
Lipase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected7 at risk EG0025 events2 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events2 affected11 at risk EG0011 events1 affected7 at risk EG0022 events1 affected5 at risk EG003
Protein urine present	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Tri-iodothyronine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
White blood cells urine positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0005 events2 affected11 at risk EG0014 events2 affected7 at risk EG0021 events1 affected5 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0012 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0012 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected11 at risk EG0012 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected11 at risk EG0013 events1 affected7 at risk EG0022 events2 affected5 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events2 affected11 at risk EG0015 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Lethargy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Seizure	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Agitation	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0023 events1 affected5 at risk EG003
Delirium	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Irritability	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events3 affected11 at risk EG0013 events2 affected7 at risk EG0020 events0 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0021 events1 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected7 at risk EG0020 events0 affected5 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected7 at risk EG0020 events0 affected5 at risk EG003

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D012509	Sarcoma
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
C545685	niraparib
D013607	Tablets
D013535	Suspensions
C000719628	dostarlimab

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D003102	Colloids
D045424	Complex Mixtures

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	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.
BG005	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.
BG006	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.
BG007	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	7	11	6	11	11	11
EG001	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.	3	7	2	7	7	7
EG002	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.	3	5	2	5	5	5
EG003	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.	3	3	2	3	3	3
EG004	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.	2	11	4	11	11	11
EG005	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.	2	7	4	7	7	7
EG006	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.	1	3	2	3	3	3