{"analyses":[{"ciLowerLimit":"0.77","ciPctValue":"95","ciUpperLimit":"1.04","estimateComment":"Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.145","paramType":"Hazard Ratio (HR)","paramValue":"0.90","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":"436"},{"groupId":"OG001","value":"392"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"890"},{"groupId":"OG001","value":"886"}],"units":"Participants"}],"description":"Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, 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 by subcutaneous injection 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 33 months","title":"Time to the First-and-Subsequent On-Study Skeletal-Related Event","type":"SECONDARY","unitOfMeasure":"Events"}