Trial Outcomes & Findings for A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer (NCT NCT03148795)

Last Updated: 2024-04-05

Results Overview

Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

128 participants

Primary outcome timeframe

From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)

Results posted on

2024-04-05

Participant Flow

Participants with measurable soft tissue disease as per response evaluation criteria in solid tumors (RECIST) 1.1 and progressive metastatic castration-resistant prostate cancer (CRPC) and deoxyribonucleic acid (DNA) damage repair deficiencies, who previously received 1 to 2 taxane-based chemotherapy, and progressed on at least 1 line of novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) were enrolled.

Participant milestones

Participant milestones
Measure	Talazoparib Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Overall Study STARTED	128
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Talazoparib Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Overall Study Progressive Disease	1

Baseline Characteristics

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talazoparib n=127 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Age, Continuous Mean	68.16 Years STANDARD_DEVIATION 8.02 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)

Population: DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.

Outcome measures

Outcome measures
Measure	Talazoparib n=104 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Best Objective Response Rate (ORR)	29.8 Percentage of participants Interval 21.2 to 39.6

SECONDARY outcome

Timeframe: From first dose of study drug to first objective response (maximum duration of 25 months)

Time to objective response was defined as the time from first dose of talazoparib to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per prostate cancer working Group 3 (PCWG3). Soft tissue response is defined as a best overall response of CR or PR per RECIST 1.1 by independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.

Outcome measures

Outcome measures
Measure	Talazoparib n=31 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Time to Objective Response	3.4 Months Interval 1.6 to 7.5

SECONDARY outcome

Timeframe: From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months)

DOR was defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) per RECIST 1.1 and no evidence of confirmed bone disease progression per PCWG3 to the date of first objective evidence of radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.

Outcome measures

Outcome measures
Measure	Talazoparib n=31 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Duration of Response (DOR)	12.8 Months Interval 6.5 to Upper limit of 95% confidence interval (CI) was not estimable as there were less number of participants with an event.

SECONDARY outcome

Timeframe: From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)

Percentage of participants with PSA response of \>= 50% was reported in this outcome measure. PSA response was calculated as a decline from baseline PSA (ng/mL) by at least 50% measured by central laboratory.

Outcome measures

Outcome measures
Measure	Talazoparib n=96 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)	45.8 Percentage of participants Interval 35.6 to 56.3

SECONDARY outcome

Timeframe: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months

Population: All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Participants with a CTC count \<5 per 7.5 mL of blood at baseline were not analyzed for this conversion outcome measure. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

Percentage of participants with conversion of CTC count was defined as percentage of participants with a CTC count \>= 5 CTC per 7.5 milliliter (mL) of blood at baseline that decreased to \< 5 CTC per 7.5 mL of blood any time on study.

Outcome measures

Outcome measures
Measure	Talazoparib n=33 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Percentage of Participants With Conversion of Circulating Tumor Cell (CTC) Count	63.6 Percentage of participants Interval 45.1 to 79.6

SECONDARY outcome

Timeframe: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months

Population: All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Participants with a CTC count 0 per 7.5 mL of blood at baseline were not analyzed for this outcome measure.Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

Percentage of participants with a null CTC count was defined as percentage of participants with CTC count \>=1 CTC per 7.5 mL of blood at baseline that decreased to CTC = 0 per 7.5 mL of blood any time on study.

Outcome measures

Outcome measures
Measure	Talazoparib n=45 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Percentage of Participants With a Null CTC Count	53.3 Percentage of participants Interval 37.9 to 68.3

SECONDARY outcome

Timeframe: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months

Population: All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

Percentage of participants with CTC count \<5 CTC per 7.5 mL of blood at baseline those who showed an increased CTC count, compared to baseline, any time on study was reported in this study.

Outcome measures

Outcome measures
Measure	Talazoparib n=29 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Percentage of Participants With Baseline CTC Count <5 CTC Showed Increased CTC Counts at Any Time on Study	37.9 Percentage of participants Interval 20.7 to 57.7

SECONDARY outcome

Time to PSA progression was defined as the time from first dose of study treatment to the date of PSA progression, which was subsequently confirmed. The time from first dose of talazoparib to the date that a \>=25% increase in PSA with an absolute increase of \>=2micogram per liter (2 nanogram per mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained \>=3 weeks (21 days) later. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Talazoparib n=104 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Time to Prostate-Specific Antigen (PSA) Progression	9.2 Months Interval 5.6 to 11.1

SECONDARY outcome

Timeframe: From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months)

Radiographic PFS was defined as the time from date of first dose of talazoparib to first objective evidence of radiographic progression as assessed in soft tissue per modified RECIST 1.1 or confirmed progression in bone per PCWG3 guidelines by independent central review or death without documented radiographic progression, whichever occurs first.

Outcome measures

Outcome measures
Measure	Talazoparib n=104 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Radiographic Progression-Free Survival (PFS)	5.6 Months Interval 3.7 to 8.8

SECONDARY outcome

Timeframe: From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)

OS was defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause. Participants who had not died were censored at the date of last contact. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Talazoparib n=104 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Overall Survival (OS)	16.9 Months Interval 13.0 to 20.7

SECONDARY outcome

Timeframe: First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious AEs and all non-serious AEs. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Talazoparib n=127 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	125 Participants

SECONDARY outcome

Timeframe: During study treatment (approximately up to 36 months)

Treatment discontinuation was defined as permanent cessation of study drug treatment administration.

Outcome measures

Outcome measures
Measure	Talazoparib n=127 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events	21 Participants

SECONDARY outcome

Timeframe: During study treatment (approximately up to 36 months)

Population: Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified rows.

Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): absolute result greater than (\>) 180 mmHg and increase from baseline greater than or equal to (\>=) 40 mmHg or absolute result \< 90 mmHg and decrease from baseline \> 30 mmHg; 2) Diastolic blood pressure (DBP) (mmHg): absolute result \> 110 mmHg and increase from baseline \>= 30 mmHg or absolute result \< 50 mmHg and decrease from baseline \> 20 mmHg or \>= 20 mmHg increase from baseline; 3) Heart rate in beats per minutes (bpm): absolute result \< 50 bpm and decrease from baseline \> 20 bpm or absolute result \> 120 bpm and increase from baseline \> 30 bpm; Weight in kilogram: \> 10% decrease from baseline.

Outcome measures

Outcome measures
Measure	Talazoparib n=125 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Clinically Significant Abnormalities in Vital Signs Weight: > 10% decrease from baseline	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: Absolute result > 180 mm Hg and increase from baseline >= 40 mm Hg	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: Absolute result < 90 mm Hg and decrease from baseline > 30 mm Hg	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: Absolute result > 110 mm Hg and increase from baseline >= 30 mm Hg	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: Absolute result < 50 mm Hg and decrease from baseline > 20 mm Hg	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: >= 20 mm Hg increase from baseline	17 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs Heart rate: Absolute result < 50 bpm and decrease from baseline > 20 bpm	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs Heart rate: Absolute result > 120 bpm and increase from baseline > 30 bpm	2 Participants

SECONDARY outcome

Timeframe: During study treatment (approximately up to 36 months)

Hematology parameters included anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, Leukocytosis and white blood cell decreased. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Outcome measures

Outcome measures
Measure	Talazoparib n=125 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Anemia	30 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Hemoglobin increased	1 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Lymphocyte count decreased	23 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Lymphocyte count increased	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Neutrophil count decreased	11 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Platelet count decreased	3 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline White blood cell decreased	5 Participants
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline Leukocytosis	0 Participants

SECONDARY outcome

Timeframe: During study treatment (approximately up to 36 months)

Chemistry parameters:alanine aminotransferase increased(inc), alkaline phosphatase inc, aspartate aminotransferase inc, blood bilirubin inc, chronic kidney disease, creatinine inc, gamma-glutamyl transferase (GGT) inc, hypercalcemia, Hyperglycemia, hyperkalemia, hypermagnesemia, hypocalcemia, Hyponatremia, hypoglycemia, hypokalemia, hypomagnesemia, hypernatremia, Hypoalbuminemia and hypophosphatemia. Severity was graded as Grade(G)1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G2:moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G3:severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; G4:life-threatening consequence, urgent intervention indicated; G5: death related to AEs.

Outcome measures

Outcome measures
Measure	Talazoparib n=126 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Alanine aminotransferase increased	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Alkaline phosphatase increased	9 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Aspartate aminotransferase increased	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Blood bilirubin increased	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Chronic kidney disease	2 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Creatinine increased	1 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline GGT increased	3 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypercalcemia	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hyperglycemia	5 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hyperkalemia	4 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypermagnesemia	1 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypernatremia	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypoalbuminemia	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypocalcemia	4 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypoglycemia	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypokalemia	0 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypomagnesemia	1 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hyponatremia	3 Participants
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline Hypophosphatemia	2 Participants

SECONDARY outcome

Timeframe: During study treatment (approximately up to 36 months)

Number of participants with dose modification due to adverse events was reported.

Outcome measures

Outcome measures
Measure	Talazoparib n=127 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With Dose Modification	37 Participants

SECONDARY outcome

Timeframe: Baseline till final analysis of the outcome measure, up to maximum duration of 25 months

Population: All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment.

Time deterioration is based on BPI-SF question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Pain intensity was to be answered on a range of 0 to 10, where 0 corresponded to no pain and 10 worst pain. Time to this event is defined as the time from the date of first dose of study treatment to onset of pain progression, where pain progression is defined as a 2-point or more increase from baseline in the question 3 score. Kaplan-Meier method was used for analysis. Average of all assessments visits is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Time to Deterioration in Pain Symptom Scores	NA Months Median and 95 % confidence interval could not be estimated due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

Population: All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.

BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-SF have 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. BPI-SF question 3 was related to participant experiencing pain at its worst in last 24 hours, score range 0 to 10, where large values corresponded to worse outcomes.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 3	-0.51 Units on a scale Standard Deviation 2.04
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 5	-1.39 Units on a scale Standard Deviation 2.55
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 7	-1.20 Units on a scale Standard Deviation 2.89
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 9	-1.25 Units on a scale Standard Deviation 2.38
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 13	-0.85 Units on a scale Standard Deviation 2.51
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 17	-1.06 Units on a scale Standard Deviation 2.73
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 21	-0.89 Units on a scale Standard Deviation 2.77
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 25	-1.14 Units on a scale Standard Deviation 3.14
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 37	-1.00 Units on a scale Standard Deviation 2.30
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 49	-1.53 Units on a scale Standard Deviation 3.50
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 61	-2.50 Units on a scale Standard Deviation 3.42
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 73	-2.80 Units on a scale Standard Deviation 5.17
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Week 85	-5.50 Units on a scale Standard Deviation 3.54
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3 Change at Follow-up	-0.25 Units on a scale Standard Deviation 3.21

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

The EQ-5D VAS score was a participant rated questionnaire where participants rated how they felt at assessment visit on a vertical VAS that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better health condition.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 3	4.16 Units on a scale Standard Deviation 17.25
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 5	4.44 Units on a scale Standard Deviation 17.26
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 7	6.61 Units on a scale Standard Deviation 17.20
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 9	6.18 Units on a scale Standard Deviation 20.21
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 13	7.68 Units on a scale Standard Deviation 16.85
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 17	7.84 Units on a scale Standard Deviation 19.40
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 21	6.63 Units on a scale Standard Deviation 19.26
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 25	5.34 Units on a scale Standard Deviation 21.50
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 37	4.65 Units on a scale Standard Deviation 19.01
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 49	8.96 Units on a scale Standard Deviation 17.55
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 61	12.75 Units on a scale Standard Deviation 19.02
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 73	1.25 Units on a scale Standard Deviation 24.89
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 85	11.50 Units on a scale Standard Deviation 25.01
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Week 97	17.00 Units on a scale
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS) Change at Follow-up	-2.87 Units on a scale Standard Deviation 21.55

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D mobility domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 1 · No Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 1 · Slight Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 1 · Moderate Problem	25 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 1 · Severe Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 1 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 3 · No Problem	36 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 3 · Slight Problem	23 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 3 · Moderate Problem	20 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 3 · Severe Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 3 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 5 · No Problem	36 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 5 · Slight Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 5 · Moderate Problem	23 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 5 · Severe Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 5 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 7 · No Problem	37 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 7 · Slight Problem	24 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 7 · Moderate Problem	22 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 7 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 7 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 9 · No Problem	38 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 9 · Slight Problem	26 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 9 · Moderate Problem	20 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 9 · Severe Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 9 · Extreme Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 13 · No Problem	28 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 13 · Slight Problem	26 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 13 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 13 · Severe Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 13 · Extreme Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 17 · No Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 17 · Slight Problem	28 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 17 · Moderate Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 17 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 17 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 21 · No Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 21 · Slight Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 21 · Moderate Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 21 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 21 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 25 · No Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 25 · Slight Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 25 · Moderate Problem	13 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 25 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 25 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 37 · No Problem	16 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 37 · Slight Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 37 · Moderate Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 37 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 37 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 49 · No Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 49 · Slight Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 49 · Moderate Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 49 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 49 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 61 · No Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 61 · Slight Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 61 · Moderate Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 61 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 61 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 73 · No Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 73 · Slight Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 73 · Moderate Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 73 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 73 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 85 · No Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 85 · Slight Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 85 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 85 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 85 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 97 · No Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 97 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 97 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 97 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Week 97 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Follow-up · No Problem	11 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Follow-up · Slight Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Follow-up · Moderate Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Follow-up · Severe Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain Follow-up · Extreme Problem	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D self-care domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 1 · No Problem	65 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 1 · Slight Problem	18 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 1 · Moderate Problem	9 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 1 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 1 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 3 · No Problem	63 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 3 · Slight Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 3 · Moderate Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 3 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 3 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 5 · No Problem	62 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 5 · Slight Problem	20 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 5 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 5 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 5 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 7 · No Problem	59 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 7 · Slight Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 7 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 7 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 7 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 9 · No Problem	64 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 9 · Slight Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 9 · Moderate Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 9 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 9 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 13 · No Problem	51 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 13 · Slight Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 13 · Moderate Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 13 · Severe Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 13 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 17 · No Problem	55 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 17 · Slight Problem	13 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 17 · Moderate Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 17 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 17 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 21 · No Problem	44 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 21 · Slight Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 21 · Moderate Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 21 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 21 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 25 · No Problem	39 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 25 · Slight Problem	13 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 25 · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 25 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 25 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 37 · No Problem	25 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 37 · Slight Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 37 · Moderate Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 37 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 37 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 49 · No Problem	18 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 49 · Slight Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 49 · Moderate Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 49 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 49 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 61 · No Problem	11 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 61 · Slight Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 61 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 61 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 61 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 73 · No Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 73 · Slight Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 73 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 73 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 73 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 85 · No Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 85 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 85 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 85 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 85 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 97 · No Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 97 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 97 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 97 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Week 97 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Follow-up · No Problem	19 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Follow-up · Slight Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Follow-up · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Follow-up · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain Follow-up · Extreme Problem	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D usual activities domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 1 · No Problem	33 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 1 · Slight Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 1 · Moderate Problem	19 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 1 · Severe Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 1 · Extreme Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 3 · No Problem	33 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 3 · Slight Problem	26 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 3 · Moderate Problem	22 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 3 · Severe Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 3 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 5 · No Problem	36 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 5 · Slight Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 5 · Moderate Problem	21 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 5 · Severe Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 5 · Extreme Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 7 · No Problem	34 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 7 · Slight Problem	24 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 7 · Moderate Problem	22 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 7 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 7 · Extreme Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 9 · No Problem	41 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 9 · Slight Problem	26 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 9 · Moderate Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 9 · Severe Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 9 · Extreme Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 13 · No Problem	36 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 13 · Slight Problem	22 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 13 · Moderate Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 13 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 13 · Extreme Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 17 · No Problem	36 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 17 · Slight Problem	21 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 17 · Moderate Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 17 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 17 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 21 · No Problem	35 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 21 · Slight Problem	13 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 21 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 21 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 21 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 25 · No Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 25 · Slight Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 25 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 25 · Severe Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 25 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 37 · No Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 37 · Slight Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 37 · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 37 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 37 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 49 · No Problem	11 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 49 · Slight Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 49 · Moderate Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 49 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 49 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 61 · No Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 61 · Slight Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 61 · Moderate Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 61 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 61 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 73 · No Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 73 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 73 · Moderate Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 73 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 73 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 85 · No Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 85 · Slight Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 85 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 85 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 85 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 97 · No Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 97 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 97 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 97 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Week 97 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Follow-up · No Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Follow-up · Slight Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Follow-up · Moderate Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Follow-up · Severe Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain Follow-up · Extreme Problem	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D pain and discomfort domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 5 · No Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 5 · Slight Problem	27 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 5 · Moderate Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 5 · Severe Problem	9 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 5 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 7 · No Problem	26 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 7 · Slight Problem	32 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 7 · Moderate Problem	23 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 7 · Severe Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 7 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 9 · No Problem	34 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 9 · Slight Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 9 · Moderate Problem	21 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 9 · Severe Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 9 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 13 · No Problem	23 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 13 · Slight Problem	33 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 13 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 13 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 13 · Extreme Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 17 · No Problem	27 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 17 · Slight Problem	25 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 17 · Moderate Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 17 · Severe Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 17 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 21 · No Problem	24 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 21 · Slight Problem	19 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 21 · Moderate Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 21 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 21 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 25 · No Problem	22 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 25 · Slight Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 25 · Moderate Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 25 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 25 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 37 · No Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 37 · Slight Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 37 · Moderate Problem	10 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 37 · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 37 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 49 · No Problem	11 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 49 · Slight Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 49 · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 49 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 49 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 61 · No Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 61 · Slight Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 61 · Moderate Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 61 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 61 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 73 · No Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 73 · Slight Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 73 · Moderate Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 73 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 73 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 85 · No Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 85 · Slight Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 85 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 85 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 85 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 97 · No Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 97 · Slight Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 97 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 97 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 97 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Follow-up · No Problem	9 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Follow-up · Slight Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Follow-up · Moderate Problem	9 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Follow-up · Severe Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Follow-up · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 1 · No Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 1 · Slight Problem	35 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 1 · Moderate Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 1 · Severe Problem	16 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 1 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 3 · No Problem	25 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 3 · Slight Problem	25 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 3 · Moderate Problem	32 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 3 · Severe Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain Week 3 · Extreme Problem	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]

EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D anxiety and depression domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.

Outcome measures

Outcome measures
Measure	Talazoparib n=97 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Follow-up · No Problem	16 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 1 · No Problem	48 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 1 · Slight Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 1 · Moderate Problem	18 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 1 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 1 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 3 · No Problem	45 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 3 · Slight Problem	27 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 3 · Moderate Problem	17 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 3 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 3 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 5 · No Problem	43 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 5 · Slight Problem	35 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 5 · Moderate Problem	16 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 5 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 5 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 7 · No Problem	45 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 7 · Slight Problem	30 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 7 · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 7 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 7 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 9 · No Problem	49 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 9 · Slight Problem	27 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 9 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 9 · Severe Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 9 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 13 · No Problem	40 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 13 · Slight Problem	23 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 13 · Moderate Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 13 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 13 · Extreme Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 17 · No Problem	40 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 17 · Slight Problem	21 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 17 · Moderate Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 17 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 17 · Extreme Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 21 · No Problem	41 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 21 · Slight Problem	15 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 21 · Moderate Problem	7 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 21 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 21 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 25 · No Problem	29 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 25 · Slight Problem	24 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 25 · Moderate Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 25 · Severe Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 25 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 37 · No Problem	20 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 37 · Slight Problem	14 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 37 · Moderate Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 37 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 37 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 49 · No Problem	12 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 49 · Slight Problem	9 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 49 · Moderate Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 49 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 49 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 61 · No Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 61 · Slight Problem	8 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 61 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 61 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 61 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 73 · No Problem	4 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 73 · Slight Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 73 · Moderate Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 73 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 73 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 85 · No Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 85 · Slight Problem	2 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 85 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 85 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 85 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 97 · No Problem	1 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 97 · Slight Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 97 · Moderate Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 97 · Severe Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Week 97 · Extreme Problem	0 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Follow-up · Slight Problem	6 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Follow-up · Moderate Problem	5 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Follow-up · Severe Problem	3 Participants
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain Follow-up · Extreme Problem	0 Participants

SECONDARY outcome

Timeframe: Pre-dose at Week 1, 5, 9 and 13

Population: Pharmacokinetic (PK) population included all participants from the safety population who had at least 1 reportable drug concentration data point. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at specified time points.

Ctrough was defined as pre-dose plasma concentration during dosing and observed directly from data.

Outcome measures

Outcome measures
Measure	Talazoparib n=92 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Pre-dose Plasma Concentration (Ctrough) of Talazoparib At Week 1	2631.898 nanograms per milliliter Geometric Coefficient of Variation 23.2043
Pre-dose Plasma Concentration (Ctrough) of Talazoparib At Week 5	4748.147 nanograms per milliliter Geometric Coefficient of Variation 63.2488
Pre-dose Plasma Concentration (Ctrough) of Talazoparib At Week 9	4213.250 nanograms per milliliter Geometric Coefficient of Variation 52.8028
Pre-dose Plasma Concentration (Ctrough) of Talazoparib At Week 13	4378.123 nanograms per milliliter Geometric Coefficient of Variation 47.5360

SECONDARY outcome

Timeframe: 2 hours post-dose at Week 1 and 5

Population: PK population included all participants from the safety population who had at least 1 reportable drug concentration data point. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at specified time points.

Plasma concentration was measured 2 hours after dosing and observed directly from data.

Outcome measures

Outcome measures
Measure	Talazoparib n=31 Participants Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Post-dose Plasma Concentration (Ctrough) of Talazoparib At week 1	2289.540 nanograms per milliliter Geometric Coefficient of Variation 51.0724
Post-dose Plasma Concentration (Ctrough) of Talazoparib At Week 5	10713.918 nanograms per milliliter Geometric Coefficient of Variation 49.4248

Adverse Events

Talazoparib

Serious events: 51 serious events

Other events: 124 other events

Deaths: 111 deaths

Serious adverse events

Serious adverse events
Measure	Talazoparib n=127 participants at risk Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Blood and lymphatic system disorders Anaemia	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Cardiac disorders Atrial fibrillation	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Cardiac disorders Cardio-respiratory arrest	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Abdominal pain	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Constipation	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Inguinal hernia	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Rectal haemorrhage	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Vomiting	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Asthenia	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Disease progression	3.9% 5/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders General physical health deterioration	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Pain	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Pyrexia	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Bronchitis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Neutropenic sepsis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Parotitis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Pneumonia	2.4% 3/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Pneumonia aspiration	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Sepsis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Urinary tract infection	3.1% 4/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Injury, poisoning and procedural complications Fall	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Injury, poisoning and procedural complications Overdose	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Injury, poisoning and procedural complications Subdural haematoma	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Platelet count decreased	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations SARS-CoV-2 test positive	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations White blood cell count decreased	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Metabolism and nutrition disorders Hyperglycaemia	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Back pain	3.1% 4/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Bursitis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 2/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Hemianopia	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Hypoaesthesia	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Paraesthesia	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Spinal cord compression	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Renal and urinary disorders Dysuria	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Renal and urinary disorders Haematuria	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Renal and urinary disorders Nephrolithiasis	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Reproductive system and breast disorders Penile pain	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Respiratory, thoracic and mediastinal disorders Asthma	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Vascular disorders Hypotension	0.79% 1/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.

Other adverse events

Other adverse events
Measure	Talazoparib n=127 participants at risk Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
Renal and urinary disorders Haematuria	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Blood and lymphatic system disorders Anaemia	52.8% 67/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Constipation	21.3% 27/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Diarrhoea	17.3% 22/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Nausea	35.4% 45/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Gastrointestinal disorders Vomiting	12.6% 16/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Asthenia	25.2% 32/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Chest pain	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Fatigue	22.0% 28/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Oedema peripheral	18.1% 23/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
General disorders Pyrexia	7.9% 10/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Upper respiratory tract infection	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Infections and infestations Urinary tract infection	7.9% 10/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Injury, poisoning and procedural complications Fall	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Alanine aminotransferase increased	5.5% 7/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Aspartate aminotransferase increased	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Lymphocyte count decreased	8.7% 11/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Neutrophil count decreased	17.3% 22/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Platelet count decreased	21.3% 27/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations Weight decreased	5.5% 7/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Investigations White blood cell count decreased	10.2% 13/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Metabolism and nutrition disorders Decreased appetite	29.9% 38/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 19/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Back pain	15.0% 19/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Bone pain	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Musculoskeletal and connective tissue disorders Pain in extremity	10.2% 13/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Dizziness	11.8% 15/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Dysgeusia	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Headache	7.1% 9/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Nervous system disorders Paraesthesia	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Psychiatric disorders Insomnia	6.3% 8/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Respiratory, thoracic and mediastinal disorders Cough	7.9% 10/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.4% 17/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Vascular disorders Hot flush	9.4% 12/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.
Vascular disorders Hypertension	5.5% 7/127 • SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study) Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER