{"analyses":[{"ciLowerLimit":"0.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.53","estimateComment":"From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \\> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.","groupDescription":"To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.","groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityComment":"A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.","nonInferiorityType":"SUPERIORITY","pValue":"0.59","pValueComment":"Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons","paramType":"Cox Proportional Hazard","paramValue":"1.10","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":"DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or 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 Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)","type":"PRIMARY","unitOfMeasure":"years"}