{"analyses":[{"ciLowerLimit":"0.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.39","estimateComment":"Estimated by use of Cox proportional hazards model.","groupDescription":"Time to PSA progression Enzalutamide Vs. Bicalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.28","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached due to the low number of events","groupId":"OG000","lowerLimit":"16.6","upperLimit":"NA","value":"19.4"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"8.3","value":"5.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for participants who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.","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 Progression","type":"SECONDARY","unitOfMeasure":"months"}