{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"565"},{"groupId":"OG001","value":"565"}]}]}],"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. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.\n\nA multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported.","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":"NUMBER","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 and Subsequent On-Study Skeletal Related Event - Number of Events","type":"SECONDARY","unitOfMeasure":"skeletal-related events"}