{"analyses":[{"ciLowerLimit":"0.99","ciPctValue":"95","ciUpperLimit":"1.59","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0561","pValueComment":"2-sided p-value","paramType":"Ratio of EDoCB","paramValue":"1.26","statisticalMethod":"Method of Ellis et al"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"667.94"},{"groupId":"OG001","value":"532.04"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"232"}],"units":"Participants"}],"description":"EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).","groups":[{"description":"Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).","id":"OG000","title":"Fulvestrant 500 mg"},{"description":"Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \\[±3\\], 28 \\[±3\\] and every 28 \\[±3\\] days thereafter).","id":"OG001","title":"Anastrozole 1 mg"}],"paramType":"NUMBER","populationDescription":"The ITT analysis set included all randomised patients.","reportingStatus":"POSTED","timeFrame":"Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)","title":"Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment","type":"SECONDARY","unitOfMeasure":"Days"}