{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \\[superiority\\] and time to first and subsequent on study SRE \\[superiority, multiple event analysis\\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.","nonInferiorityType":"SUPERIORITY","pValue":"0.82","statisticalComment":"Based on a log rank test stratified by randomization stratification factors.","statisticalMethod":"Log Rank"}],"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 - Superiority Analysis","type":"SECONDARY","unitOfMeasure":"days"}