{"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"],"nonInferiorityComment":"A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"<0.0001","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 non-inferiority 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 (SRE) (Non-inferiority)","type":"PRIMARY","unitOfMeasure":"Participants"}