{"analyses":[{"ciLowerLimit":"0.341","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.500","estimateComment":"Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \\> 6 months) and use of osteoclast-targeted therapy (No, Yes).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.000001","paramType":"Hazard Ratio (HR)","paramValue":"0.413","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = value cannot be estimated due to censored data, insufficient number of participants with events","groupId":"OG000","lowerLimit":"34.33","upperLimit":"NA","value":"40.37"},{"groupId":"OG001","lowerLimit":"15.51","upperLimit":"22.34","value":"18.43"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"955"},{"groupId":"OG001","value":"554"}],"units":"Participants"}],"description":"Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \\[DB\\] + open-label \\[OL\\]).","id":"OG000","title":"Darolutamide (BAY1841788)"},{"description":"Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \\[CO\\]).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From randomization to the time approximately 385 MFS events were observed (approximately 48 months)","title":"Metastasis-Free Survival","type":"PRIMARY","unitOfMeasure":"months"}