{"analyses":[{"ciLowerLimit":"26.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"65.30","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This secondary endpoint was not adjusted for multiple comparisons.","paramType":"Difference in objective response rate","paramValue":"46.05","statisticalComment":"Based on unstratified Cochran-Mantel-Haenszel mean score test.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.11","upperLimit":"76.13","value":"60.0"},{"groupId":"OG001","lowerLimit":"5.30","upperLimit":"27.93","value":"14.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"43"}],"units":"Participants"}],"description":"Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.","id":"OG001","title":"Bicalutamide"}],"paramType":"NUMBER","populationDescription":"All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.","title":"Best Overall Soft Tissue Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}