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Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"EG000","otherNumAffected":339,"otherNumAtRisk":353,"seriousNumAffected":123,"seriousNumAtRisk":353,"title":"Enzalutamide + Leuprolide"},{"deathsNumAffected":55,"deathsNumAtRisk":358,"description":"Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"EG001","otherNumAffected":341,"otherNumAtRisk":354,"seriousNumAffected":112,"seriousNumAtRisk":354,"title":"Placebo + Leuprolide"},{"deathsNumAffected":42,"deathsNumAtRisk":355,"description":"Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"EG002","otherNumAffected":345,"otherNumAtRisk":354,"seriousNumAffected":131,"seriousNumAtRisk":354,"title":"Enzalutamide Monotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":353},{"groupId":"EG001","numAffected":11,"numAtRisk":354},{"groupId":"EG002","numAffected":17,"numAtRisk":354}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 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