{"analyses":[{"ciLowerLimit":"0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.11","estimateComment":"From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.","groupDescription":"To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.","groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityComment":"No multiplicity adjustment was applied.","nonInferiorityType":"SUPERIORITY","pValue":"0.10","paramType":"Cox Proportional Hazard","paramValue":"0.60","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not applicable, estimates cannot be calculated due to too few events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not applicable, estimates cannot be calculated due to too few events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not applicable, estimates cannot be calculated due to too few events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not applicable, estimates cannot be calculated due to too few events.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"450"},{"groupId":"OG001","value":"450"},{"groupId":"OG002","value":"453"},{"groupId":"OG003","value":"450"}],"units":"Participants"}],"description":"OS is defined as time from randomization to death from any cause","dispersionType":"Inter-Quartile Range","groups":[{"description":"Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)\n\nanastrozole: 1 mg/d\n\nzoledronic acid: 4 mg q6m\n\ngoserelin: 3.6 mg goserelin subcutaneously every 28 days","id":"OG000","title":"AZ (Arimidex+Zoledronate)"},{"description":"Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)\n\ntamoxifen: 20 mg/d\n\nzoledronic acid: 4 mg q6m\n\ngoserelin: 3.6 mg goserelin subcutaneously every 28 days","id":"OG001","title":"TZ (Tamoxifen+Zoledronate)"},{"description":"Study Drug Arimidex (Anastrozole)\n\nanastrozole: 1 mg/d\n\ngoserelin: 3.6 mg goserelin subcutaneously every 28 days","id":"OG002","title":"AC (Arimidex Control)"},{"description":"Study Drug Nolvadex (Tamoxifen)\n\ntamoxifen: 20 mg/d\n\ngoserelin: 3.6 mg goserelin subcutaneously every 28 days","id":"OG003","title":"TC (Tamoxifen Control)"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.","title":"Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"years"}