{"analyses":[{"ciLowerLimit":"0.181","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.320","estimateComment":"Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \\< 1 favoring enzalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).","paramType":"Hazard Ratio (HR)","paramValue":"0.240","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the 95% confidence interval was not available because an insufficient number of participants had an event at the time of analysis.","groupId":"OG000","lowerLimit":"16.5","upperLimit":"NA","value":"19.4"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"8.1","value":"5.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.","id":"OG001","title":"Bicalutamide"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population: all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}