Trial Outcomes & Findings for A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) (NCT NCT03207347)

NCT ID: NCT03207347

Last Updated: 2023-09-15

Results Overview

Determine the objective response rate (ORR), which is defined as the percentage of subjects achieving a best overall response of partial or complete response (according to RECIST v1.1 criteria) from the start of the treatment until disease progression/recurrence or 30 days after the end of treatment, whichever occurs first. Per RECIST v1.1 criteria, a partial response is defined as a 30% or more decrease in the sum of the largest diameters of the target lesions. Per RECIST v1.1 criteria, a complete response is defined as the disappearance of target lesions (lymph nodes identified as lesions must have reduction in short axis to \<10 mm).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

1 year

Results posted on

2023-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B (Closed to Enrollment) This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Overall Study STARTED	23	14
Overall Study COMPLETED	23	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=23 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B (Closed to Enrollment) n=14 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	8 Participants n=107 Participants	15 Participants n=206 Participants
Age, Categorical >=65 years	16 Participants n=99 Participants	6 Participants n=107 Participants	22 Participants n=206 Participants
Age, Continuous	65.57 years n=99 Participants	61.43 years n=107 Participants	64.00 years n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	1 Participants n=107 Participants	14 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=99 Participants	14 Participants n=107 Participants	37 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	13 Participants n=107 Participants	34 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	23 participants n=99 Participants	14 participants n=107 Participants	37 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The analysis population for both cohorts only includes those subjects with at least one RECIST response assessment at the end of treatment. 6 subjects (5 subjects in Cohort A and 1 subject in Cohort B) did not have at lease one RECIST response assessment at the end of treatment and are not included in the analysis population.

Outcome measures

Outcome measures
Measure	Cohort A n=18 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=13 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Objective Response Rate (ORR)	5.6 percentage of subjects Interval 0.1 to 27.3	0 percentage of subjects Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 8 months

Determine the median progression-free survival. Progression-free survival is defined as the duration of time from study entry to time of progression or death or the date of last contact, whichever occurs first. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Cohort A n=23 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=14 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Progression-Free Survival	2.1 months Interval 1.8 to 9.1	7.2 months Interval 1.8 to 12.5

SECONDARY outcome

Timeframe: 3 months

Determine the progression-free survival rate at 3 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 3 months after study entry. Disease progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Cohort A n=23 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=14 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Progression-Free Survival Rate at 3 Months	43 percentage of subjects Interval 23.0 to 62.0	64 percentage of subjects Interval 34.0 to 83.0

SECONDARY outcome

Timeframe: 6 months

Determine the progression-free survival rate at 6 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 6 months after study entry. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Cohort A n=23 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=14 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Progression-Free Survival Rate at 6 Months	39 percentage of subjects Interval 20.0 to 58.0	57 percentage of subjects Interval 28.0 to 78.0

SECONDARY outcome

Timeframe: 10 months

Estimate the median overall survival. Overall survival is defined as the duration of time from date of study entry until date of death or date of last contact.

Outcome measures

Outcome measures
Measure	Cohort A n=23 Participants This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=14 Participants This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Overall Survival	9.1 months Interval 2.0 to 13.0	7.2 months Interval 2.9 to 15.5

Adverse Events

Cohort A

Serious events: 8 serious events

Other events: 23 other events

Deaths: 23 deaths

Cohort B

Serious events: 7 serious events

Other events: 14 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Cohort A n=23 participants at risk This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.	Cohort B n=14 participants at risk This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Gastrointestinal disorders Abdominal distension	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal pain	21.7% 5/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	35.7% 5/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alanine aminotransferase increased	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Alkaline phosphatase increased	30.4% 7/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Anemia	30.4% 7/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Anorexia	39.1% 9/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	50.0% 7/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Anxiety	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Ascites	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Aspartate aminotransferase increased	13.0% 3/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Bloating	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Enlarged groin lymph nodes	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Blood bilirubin increased	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Bruising	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Chills	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Constipation	39.1% 9/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	35.7% 5/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Cough	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Creatinine increased	17.4% 4/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Dehydration	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Depression	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dizziness	21.7% 5/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Eye disorders Dry eye	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Dry mouth	8.7% 2/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	21.7% 5/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	35.7% 5/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema limbs	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	14.3% 2/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Esophageal ulcer	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Eye disorders Itchy eyes	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fatigue	73.9% 17/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	57.1% 8/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fever	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	28.6% 4/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Flu like symptoms	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Oral petechia	4.3% 1/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	0.00% 0/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Headache	17.4% 4/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	21.4% 3/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Ear and labyrinth disorders Hearing impaired	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Hematuria	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.
Hepatobiliary disorders Transaminitis	0.00% 0/23 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.	7.1% 1/14 • Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days. All adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator. Adverse events were assessed by physical examination, labs, and subject self-reports.