{"analyses":[{"ciLowerLimit":"0.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.54","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.43","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.44","upperLimit":"8.05","value":"6.93"},{"groupId":"OG001","lowerLimit":"2.76","upperLimit":"4.14","value":"2.83"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"485"},{"groupId":"OG001","value":"239"}],"units":"Participants"}],"description":"Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Everolimus 10 mg daily in combination with exemestane 25 mg daily","id":"OG000","title":"Everolimus + Exemestane"},{"description":"Placebo of everolimus in combination with exemestane 25 mg daily","id":"OG001","title":"Placebo + Exemestane"}],"paramType":"MEDIAN","populationDescription":"All randomized patients were included in the Full Analysis Set.","reportingStatus":"POSTED","timeFrame":"date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months","title":"Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.","type":"PRIMARY","unitOfMeasure":"months"}