{"analyses":[{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0515","paramType":"Hazard Ratio (HR)","paramValue":"0.816","statisticalComment":"Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).","statisticalMethod":"Cox Proportional Hazards Model"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached due to the low number of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not reached due to the low number of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1709"},{"groupId":"OG001","value":"1711"}],"units":"Participants"}],"description":"DFS was defined as the time interval from the randomization date to the date of first evidence of local or distant metastases, contra-lateral breast cancer, secondary carcinoma, or death from any cause (whichever occurred first). Participants last known to be alive, who did not experience recurrence of disease, were censored at their last contact date or at the data cut-off date whichever came first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"OG000","title":"Placebo"},{"description":"Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"OG001","title":"Denosumab"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set: all randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization until the DFS data cut-off date of 15 September 2015; maximum time on main study at the cut-off was 102 months","title":"Disease-free Survival (DFS)","type":"SECONDARY","unitOfMeasure":"Days"}