{"analyses":[{"ciLowerLimit":"-11.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.75","estimateComment":"Difference in objective response rate was based upon standard normal approximation.","groupDescription":"This analysis is reported for participants with CR+PR.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1653","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 Objective Response Rate","paramValue":"-5.00","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-10.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"32.21","estimateComment":"Difference in objective response rate was based upon standard normal approximation.","groupDescription":"This analysis is reported for participants with CR+PR+SD.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3216","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 Objective Response Rate","paramValue":"10.92","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.00","upperLimit":"9.25","value":"0.0"},{"groupId":"OG001","lowerLimit":"0.61","upperLimit":"16.92","value":"5.0"}]}],"title":"CR + PR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.35","upperLimit":"82.50","value":"68.4"},{"groupId":"OG001","lowerLimit":"40.89","upperLimit":"72.96","value":"57.5"}]}],"title":"CR + PR + SD"}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \\<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \\>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.","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":"ITT population (with measurable disease at screening) included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}