{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}],"title":"Alanine Aminotransferase: High Value"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Alkaline Phosphatase: High Value"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}]}],"title":"Aspartate Aminotransferase: High Value"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"Bilirubin: High Value"}],"denoms":[{"counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"description":"Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.","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 Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry","type":"SECONDARY","unitOfMeasure":"Participants"}