{"analyses":[{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.16","estimateComment":"A hazard ratio (denosumab:zoledronic acid) \\< 1 favors denosumab.","groupDescription":"The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.","groupIds":["OG000","OG001"],"nonInferiorityComment":"If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.","nonInferiorityType":"SUPERIORITY","pValue":"0.41","paramType":"Hazard Ratio (HR)","paramValue":"0.90","statisticalMethod":"Cox proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"comment":"Not estimable, the median survival and 95% CI were not reached","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The 95% CI was not estimable as there were no participants in the risk set who survived at the median time","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"1507.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"859"},{"groupId":"OG001","value":"859"}],"units":"Participants"}],"description":"Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was 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":"Overall Survival","type":"SECONDARY","unitOfMeasure":"days"}