{"analyses":[{"ciLowerLimit":"0.20","ciPctValue":"95","ciUpperLimit":"0.46","groupDescription":"Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"P-value is based on an unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.31","statisticalMethod":"Unstratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events","groupId":"OG000","lowerLimit":"10.97","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"3.61","upperLimit":"11.33","value":"5.29"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"190"}],"units":"Participants"}],"description":"Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).","id":"OG000","title":"Enzalutamide"},{"description":"Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"ITT population with available data.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the rPFS event (deaths from any cause and radiographic disease progression) median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo","title":"Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment","type":"SECONDARY","unitOfMeasure":"Months"}