{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"SBP: AB>180 mmHg and IFB >=40 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"}]}],"title":"SBP: AB<90 mmHg and DFB >30 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"DBP: AB>110 mmHg and IFB >=30 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"7"}]}],"title":"DBP: AB<50 mmHg and DFB>20 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"13"}]}],"title":"DBP: IFB>=20 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Heart rate: AB >120 bpm and IFB >30 bpm"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Heart rate: AB <50 bpm and DFB >20 bpm"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"13"}]}],"title":"Weight: >10% DFB"}],"denoms":[{"counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"description":"Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (\\>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (\\>=) 40 mmHg, 2) absolute results less than (\\<) 90 mmHg and decrease from baseline (DFB) \\>30 mmHg; b) Diastolic blood pressure: 1) absolute results \\>110 mmHg and \\>=30 mmHg increase from baseline, 2) absolute results \\<50 mmHg and \\>20 mmHg decrease from baseline 3) \\>=20 mmHg increase from baseline; c) Heart rate: 1) absolute results\\>120 beats per minute \\[bpm\\] and \\>30 bpm increase from baseline, 2) absolute results \\<50 bpm and \\>20 bpm decrease from baseline and d) Weight: \\>10 percent \\[%\\] decrease from baseline.","groups":[{"description":"Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.","id":"OG000","title":"Talazoparib"},{"description":"Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\\^2 (equivalent to eribulin 1.23 mg/ m\\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.","id":"OG001","title":"Physician's Choice Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).","reportingStatus":"POSTED","timeFrame":"Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months","title":"Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs","type":"SECONDARY","unitOfMeasure":"Participants"}