{"analyses":[{"ciLowerLimit":"0.71","ciPctValue":"95","ciUpperLimit":"0.94","estimateComment":"Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0085","paramType":"Rate ratio","paramValue":"0.82","statisticalComment":"P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.","statisticalMethod":"Anderson-Gill model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"584"},{"groupId":"OG001","value":"494"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"951"},{"groupId":"OG001","value":"950"}],"units":"Participants"}],"description":"Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.\n\nThis outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.","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":"NUMBER","populationDescription":"Full Analysis Set, composed of all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to 40.5 months","title":"Time to the First-And-Subsequent On-Study SRE","type":"SECONDARY","unitOfMeasure":"Events"}