{"analyses":[{"ciLowerLimit":"0.85","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.14","estimateComment":"A hazard ratio (denosumab:zoledronic acid) \\< 1 favors denosumab","groupIds":["OG000","OG001"],"nonInferiorityComment":"A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \\[95% CI\\] of 1.48 \\[1.28, 1.71\\] for placebo vs zoledronic acid.","nonInferiorityType":"NON_INFERIORITY","pValue":"0.010","paramType":"Hazard Ratio (HR)","paramValue":"0.98","statisticalComment":"Based on a Cox proportional hazards model stratified by the randomization stratification factors.","statisticalMethod":"Cox proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"504.0","upperLimit":"1014.0","value":"730.0"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"448.0","upperLimit":"NA","value":"695.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"859"},{"groupId":"OG001","value":"859"}],"units":"Participants"}],"description":"A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.","id":"OG000","title":"Zoledronic Acid"},{"description":"Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.","id":"OG001","title":"Denosumab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.","title":"Time to First On-study Skeletal Related Event","type":"PRIMARY","unitOfMeasure":"days"}