PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.

Group 2: All randomized participants with suspected deleterious or deleterious breast cancer gene (BRCA)1 or BRCA2 mutation determined by sponsor core lab.

Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1.

CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: >= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of >=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with at least 1 measurable lesion at baseline.

EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with a baseline and post baseline value. Per protocol, this outcome measure was not planned for the Veliparib + TMZ arm.