{"analyses":[{"ciLowerLimit":"48.53","ciPctValue":"95","ciUpperLimit":"59.17","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.","paramType":"Difference in objective response rate","paramValue":"53.85","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.8"},{"groupId":"OG001","value":"5.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"381"}],"units":"Participants"}],"description":"The best overall soft tissue objective response is defined as partial response \\[PR\\] or complete response \\[CR\\] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.","groups":[{"description":"Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received placebo, administered as four capsules, once per day by mouth.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.","reportingStatus":"POSTED","timeFrame":"During study period (up to 3 years)","title":"Best Overall Soft Tissue Response","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}