{"analyses":[{"ciLowerLimit":"-4.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.51","estimateComment":"Difference in response rate was based upon standard normal approximation.","groupDescription":"This analysis is reported for participants with \\>=50% decrease from baseline in PSA response.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3101","pValueComment":"P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\\>=0% to \\<30% vs \\>=30%) at Week 13 in the open-label period.","paramType":"Difference in Response Rate","paramValue":"-1.65","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-3.90","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.82","estimateComment":"Difference in response rate was based upon standard normal approximation.","groupDescription":"This analysis is reported for participants with \\>=30% decrease from baseline in PSA response.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.9917","pValueComment":"P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\\>=0% to \\<30% vs \\>=30%) at Week 13 in the open-label period.","paramType":"Difference in Response Rate","paramValue":"-0.04","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"4.4","value":"0.8"},{"groupId":"OG001","lowerLimit":"0.5","upperLimit":"7.0","value":"2.5"}]}],"title":">= 50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"6.9","value":"2.4"},{"groupId":"OG001","lowerLimit":"0.5","upperLimit":"7.0","value":"2.5"}]}],"title":">= 30%"}],"denoms":[{"counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"PSA response rate was defined as percentage of participants with \\>=30% and \\>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"OG000","title":"Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg"},{"description":"Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"OG001","title":"Placebo+Abiraterone 1000mg+ Prednisone 10mg"}],"paramType":"NUMBER","populationDescription":"Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)","title":"Prostate Specific Antigen (PSA) Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}