{"analyses":[{"ciLowerLimit":"0.71","ciPctValue":"95","ciUpperLimit":"0.98","groupIds":["OG000","OG001"],"nonInferiorityComment":"A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.0007","paramType":"Hazard Ratio (HR)","paramValue":"0.84","statisticalComment":"Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"371.00","upperLimit":"589.00","value":"496.0"},{"comment":"Upper limit could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"456.00","upperLimit":"NA","value":"625.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"890"},{"groupId":"OG001","value":"886"}],"units":"Participants"}],"description":"Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.","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 by subcutaneous injection 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 33 months","title":"Time to the First On-Study Skeletal-Related Event (Non-Inferiority)","type":"PRIMARY","unitOfMeasure":"Days"}