{"analyses":[{"ciLowerLimit":"70.91","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"77.02","groupDescription":"Decrease from Baseline \\>= 50%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\\<6 months, \\>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.","paramType":"Difference in Response Rate","paramValue":"73.96","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"52.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"58.76","groupDescription":"Decrease from Baseline \\>= 90%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\\<6 months, \\>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS","paramType":"Difference in Response Rate","paramValue":"55.52","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"7.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.54","groupDescription":"Decrease to Undetectable Level","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\\<6 months, \\>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.","paramType":"Difference in Response Rate","paramValue":"9.65","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.5","upperLimit":"79.0","value":"76.3"},{"groupId":"OG001","lowerLimit":"1.2","upperLimit":"4.2","value":"2.4"}]}],"title":"Decrease from Baseline >= 50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.7","upperLimit":"59.2","value":"55.9"},{"groupId":"OG001","lowerLimit":"0.1","upperLimit":"1.5","value":"0.4"}]}],"title":"Decrease from Baseline >= 90%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.8","upperLimit":"11.7","value":"9.6"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"0.8","value":"0"}]}],"title":"Decrease to Undetectable Level"}],"denoms":[{"counts":[{"groupId":"OG000","value":"933"},{"groupId":"OG001","value":"468"}],"units":"Participants"}],"description":"PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.","id":"OG000","title":"Enzalutamide 160 mg"},{"description":"Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Overall number of participants analyzed' = participants with baseline and at least one post-baseline PSA assessment.","reportingStatus":"POSTED","timeFrame":"From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)","title":"Percentage of Participants With Prostate Specific Antigen (PSA) Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}