{"analyses":[{"ciLowerLimit":"0.654","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.997","estimateComment":"A hazard ratio \\< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.","nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.808"}],"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":"BMFS was defined as the time interval from randomization to first occurrence of bone metastasis or death from any cause, whichever comes first. Participants last known to be alive, who did not experience bone metastasis, were censored at their last assessment (i.e., bone scan) date or at the last contact date, whichever comes 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 end of main study, maximum time on main study was 152 months","title":"Bone Metastases-free Survival (BMFS)","type":"SECONDARY","unitOfMeasure":"Days"}