{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.02","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalComment":"Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.6","upperLimit":"13.8","value":"10.3"},{"groupId":"OG001","lowerLimit":"3.0","upperLimit":"8.0","value":"5.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. 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 lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Fulvestrant Day 1 \\& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.\n\nFulvestrant: Fulvestrant 500 mg Day 1 \\& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.\n\nEverolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.","id":"OG000","title":"Fulvestrant & Everolimus"},{"description":"Fulvestrant Day 1 \\& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.\n\nFulvestrant: Fulvestrant 500 mg Day 1 \\& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).\n\nIf no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.\n\nPlacebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.","id":"OG001","title":"Fulvestrant & Placebo"}],"paramType":"MEDIAN","populationDescription":"all randomized patients","reportingStatus":"POSTED","timeFrame":"Every 3 months until progression or up to 3 years","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"months"}