{"analyses":[{"ciLowerLimit":"0.66","ciPctValue":"95","ciUpperLimit":"0.89","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":"0.001","pValueComment":"P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure","paramType":"Rate ratio","paramValue":"0.77","statisticalMethod":"Anderson-Gill model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"608"},{"groupId":"OG001","value":"474"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1020"},{"groupId":"OG001","value":"1026"}],"units":"Participants"}],"description":"Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events.","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 and Subsequent On-Study Skeletal-Related Event","type":"SECONDARY","unitOfMeasure":"Events"}