{"analyses":[{"ciLowerLimit":"0.137","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.264","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 CRF.","paramType":"Hazard Ratio (HR)","paramValue":"0.190","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median time to PSA progression and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.","groupId":"OG000","lowerLimit":"19.4","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"5.7","upperLimit":"8.5","value":"8.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"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 at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA 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":"Time to PSA Progression","type":"SECONDARY","unitOfMeasure":"months"}