{"analyses":[{"ciLowerLimit":"3.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.09","estimateComment":"Estimated by use of Cox proportional hazards model.","groupDescription":"Time to PSA Enzalutamide Vs. Bicalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"5.07","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.9","upperLimit":"5.6","value":"3.0"},{"comment":"Not reached due to the low number of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG001","title":"Bicalutamide"}],"paramType":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.","title":"Time to PSA ≤ 4 ng/mL","type":"SECONDARY","unitOfMeasure":"months"}