{"analyses":[{"ciLowerLimit":"0.71","ciPctValue":"95","ciUpperLimit":"0.95","estimateComment":"Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)","groupIds":["OG000","OG001"],"nonInferiorityComment":"A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"0.82","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"456.00","upperLimit":"592.00","value":"521.0"},{"groupId":"OG001","lowerLimit":"573.00","upperLimit":"757.00","value":"629.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"951"},{"groupId":"OG001","value":"950"}],"units":"Participants"}],"description":"Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks","id":"OG000","title":"Zoledronic Acid"},{"description":"Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks","id":"OG001","title":"Denosumab"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set, composed of all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to 40.5 months","title":"Time to the First On-Study SRE (Non-inferiority)","type":"PRIMARY","unitOfMeasure":"Days"}