{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.65","estimateComment":"From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.","groupDescription":"The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.504","statisticalComment":"Stratification factors are hospital type, prior use of aromatase inhibitor, and 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":"The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.","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 primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months","title":"Time to First Clinical Fracture","type":"PRIMARY","unitOfMeasure":"Days"}