{"analyses":[{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.94","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.007","paramType":"Hazard Ratio (HR)","paramValue":"0.80","statisticalComment":"Two-sided stratified log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.1","upperLimit":"15.1","value":"13.5"},{"groupId":"OG001","lowerLimit":"13.2","upperLimit":"18.4","value":"15.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"349"}],"units":"Participants"}],"description":"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive oral anastrozole once daily on days 1-28.\n\nanastrozole: Given orally","id":"OG000","title":"Arm I Anastrozole"},{"description":"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.\n\nanastrozole: Given orally\n\nfulvestrant: Given intramuscularly","id":"OG001","title":"Arm II Anastrozole and Fulvestrant"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.","title":"Time to Tumor Progression","type":"PRIMARY","unitOfMeasure":"months"}