{"analyses":[{"ciLowerLimit":"0.71","ciPctValue":"95","ciUpperLimit":"0.95","estimateComment":"Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.010","pValueComment":"P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure","paramType":"Hazard Ratio (HR)","paramValue":"0.82","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"315"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1020"},{"groupId":"OG001","value":"1026"}],"units":"Participants"}],"description":"Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.","groups":[{"description":"Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks","id":"OG000","title":"Zoledronic Acid"},{"description":"Denomsumab 120 mg subcutaneously with 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 34 months","title":"Time to First On-Study Skeletal-Related Event (Superiority)","type":"SECONDARY","unitOfMeasure":"Participants"}