{"analyses":[{"ciLowerLimit":"10.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"28.2","groupDescription":"ORR Treatment Comparison","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.","paramType":"Difference in rate","paramValue":"19.3","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"76.7","upperLimit":"88.3","value":"83.1"},{"groupId":"OG001","lowerLimit":"56.3","upperLimit":"70.7","value":"63.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"177"},{"groupId":"OG001","value":"182"}],"units":"Participants"}],"description":"The ORR was calculated as the percentage of participants who achieved a completed response (CR) or a partial response (PR) (unconfirmed responses) in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by ICR.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG000","title":"Enzalutamide + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG001","title":"Placebo + Androgen Deprivation Therapy (ADT)"}],"paramType":"NUMBER","populationDescription":"ITT participants with measurable disease at baseline","reportingStatus":"POSTED","timeFrame":"From date of randomization up to 26.6 months","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}