{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.01","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.509","upperLimit":"0.751","value":"0.636"},{"groupId":"OG001","lowerLimit":"0.294","upperLimit":"0.544","value":"0.415"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"Clinical benefit rate is defined as number of patients with objective response (complete response or partial response) or stable disease for at least 24 weeks divided by number of patients randomized in each arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR) is defined as \\>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease; Complete Response (CR) is defined as disappearance of all target 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":"NUMBER","populationDescription":"all randomized patients","reportingStatus":"POSTED","timeFrame":"Every 3 months until progression or up to 3 years","title":"Clinical Benefit Rate","type":"SECONDARY","unitOfMeasure":"proportion of patients"}