{"analyses":[{"ciLowerLimit":"0.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.14","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":"0.70","paramType":"Hazard Ratio (HR)","paramValue":"0.97","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":"12.1","upperLimit":"15.0","value":"13.5"},{"groupId":"OG001","lowerLimit":"11.6","upperLimit":"14.3","value":"12.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2253"},{"groupId":"OG001","value":"2256"}],"units":"Participants"}],"description":"BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date.\n\nBone metastasis must have been confirmed by central imaging analysis or by biopsy, Evidence of disseminated tumor cells in bone marrow was not sufficient for determination of disease recurrence. Development of new primary malignancy in bone was not considered as bone metastasis.\n\nSince the median BMSF time could not be estimated due to low number of events, the percentage of participants with an event (i.e., bone metastasis 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":"Bone Metastasis-free Survival (BMFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}