{"analyses":[{"ciLowerLimit":"47.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"64.2","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.","paramType":"Difference of response rate","paramValue":"55.8","statisticalMethod":"Unstratified Cochran-Mantel-Haenszel %"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"148"}],"units":"Participants"}],"description":"Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.","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":"NUMBER","populationDescription":"ITT population with available data.","reportingStatus":"POSTED","timeFrame":"From baseline to the lowest post-baseline PSA result median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo","title":"Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)","type":"SECONDARY","unitOfMeasure":"Participants"}