{"analyses":[{"ciLowerLimit":"0.92","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.21","estimateComment":"Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \\< 1 favors denosumab.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.41","paramType":"Hazard Ratio (HR)","paramValue":"1.06","statisticalComment":"Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.4","upperLimit":"19.6","value":"18.0"},{"groupId":"OG001","lowerLimit":"17.1","upperLimit":"20.3","value":"18.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2253"},{"groupId":"OG001","value":"2256"}],"units":"Participants"}],"description":"Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date.\n\nDistant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence.\n\nSince the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.","id":"OG000","title":"Placebo"},{"description":"Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.","id":"OG001","title":"Denosumab"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.","title":"Distant Recurrence-free Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}