{"analyses":[{"ciLowerLimit":"0.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.50","estimateComment":"Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.","groupDescription":"rPFS Treatment Comparison","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.","paramType":"Cox hazard ratio","paramValue":"0.39","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG001","lowerLimit":"16.59","upperLimit":"NA","value":"19.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"576"}],"units":"Participants"}],"description":"rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as \"not evaluable (NE),\" rPFS was censored on the date of randomization.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG000","title":"Enzalutamide + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG001","title":"Placebo + Androgen Deprivation Therapy (ADT)"}],"paramType":"MEDIAN","populationDescription":"ITT population is defined as all participants who were randomized in this study.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)","title":"Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria","type":"PRIMARY","unitOfMeasure":"months"}