{"description":"The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":13,"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). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":6,"seriousNumAtRisk":13,"title":"Part 1: Talazoparib 1 mg QD+Enzalutamide"},{"deathsNumAffected":2,"deathsNumAtRisk":6,"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). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.","id":"EG001","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Part 1: Talazoparib 0.5 mg QD+Enzalutamide"},{"deathsNumAffected":123,"deathsNumAtRisk":402,"description":"Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.","id":"EG002","otherNumAffected":377,"otherNumAtRisk":398,"seriousNumAffected":157,"seriousNumAtRisk":398,"title":"Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)"},{"deathsNumAffected":129,"deathsNumAtRisk":403,"description":"Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.","id":"EG003","otherNumAffected":351,"otherNumAtRisk":401,"seriousNumAffected":107,"seriousNumAtRisk":401,"title":"Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)"},{"deathsNumAffected":43,"deathsNumAtRisk":200,"description":"Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received talazoparib+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.","id":"EG004","otherNumAffected":190,"otherNumAtRisk":198,"seriousNumAffected":60,"seriousNumAtRisk":198,"title":"Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide"},{"deathsNumAffected":53,"deathsNumAtRisk":199,"description":"Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received placebo+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.","id":"EG005","otherNumAffected":182,"otherNumAtRisk":199,"seriousNumAffected":40,"seriousNumAtRisk":199,"title":"Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":6},{"groupId":"EG002","numAffected":258,"numAtRisk":398},{"groupId":"EG003","numAffected":70,"numAtRisk":401},{"groupId":"EG004","numAffected":127,"numAtRisk":198},{"groupId":"EG005","numAffected":30,"numAtRisk":199}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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