{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"}]}],"title":"Participants with TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Participants with medication error TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"Participants with serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"}]}],"title":"Participants with Maximum Grade 3 or 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Participants with Maximum Grade 5 TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.","groups":[{"description":"Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).","id":"OG000","title":"Part 1: Talazoparib 1 mg QD+Enzalutamide"},{"description":"Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).","id":"OG001","title":"Part 1: Talazoparib 0.5 mg QD+Enzalutamide"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).","reportingStatus":"POSTED","timeFrame":"Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)","title":"Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1","type":"PRIMARY","unitOfMeasure":"Participants"}