{"analyses":[{"ciLowerLimit":"0.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.67","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.48","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.8","upperLimit":"93.5","value":"90.1"},{"groupId":"OG001","lowerLimit":"64.3","upperLimit":"82.4","value":"74.6"}]}],"title":"2 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"74.9","upperLimit":"86.2","value":"81.2"},{"groupId":"OG001","lowerLimit":"38.1","upperLimit":"59.2","value":"49.1"}]}],"title":"4 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"65.0","upperLimit":"78.0","value":"72.1"},{"groupId":"OG001","lowerLimit":"29.5","upperLimit":"50.5","value":"40.1"}]}],"title":"6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"54.8","upperLimit":"69.1","value":"62.4"},{"groupId":"OG001","lowerLimit":"25.4","upperLimit":"46.2","value":"35.8"}]}],"title":"8 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.0","upperLimit":"59.0","value":"51.7"},{"groupId":"OG001","lowerLimit":"21.3","upperLimit":"41.7","value":"31.3"}]}],"title":"10 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.7","upperLimit":"51.8","value":"44.4"},{"groupId":"OG001","lowerLimit":"18.5","upperLimit":"38.6","value":"28.1"}]}],"title":"12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.5","upperLimit":"47.6","value":"40.1"},{"groupId":"OG001","lowerLimit":"16.9","upperLimit":"36.8","value":"26.4"}]}],"title":"15 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24.1","upperLimit":"39.8","value":"31.8"},{"groupId":"OG001","lowerLimit":"15.0","upperLimit":"34.9","value":"24.4"}]}],"title":"18 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.0","upperLimit":"36.8","value":"27.6"},{"groupId":"OG001","lowerLimit":"9.0","upperLimit":"28.2","value":"17.4"}]}],"title":"21 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.0","upperLimit":"32.5","value":"22.0"},{"groupId":"OG001","lowerLimit":"9.0","upperLimit":"28.2","value":"17.4"}]}],"title":"24 months"},{"categories":[{"measurements":[{"comment":"Not estimable due to the low number of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"9.0","upperLimit":"28.2","value":"17.4"}]}],"title":"27 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the date of the first documented tumor progression or death from any cause, whichever comes first.\n\nProgression was defined using modified RECIST 1.0 and as per central radiology assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Progression was assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).\n\nFor participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown.\n\nThe percentage event-free probability estimate is the estimated probability that a patient will remain event-free in PFS up to the specified time point.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received everolimus 10 mg once daily BSC throughout the study","id":"OG000","title":"Everolimus + BSC"},{"description":"Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period","id":"OG001","title":"Placebo + BSC"}],"paramType":"NUMBER","populationDescription":"The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.","reportingStatus":"POSTED","timeFrame":"From date of randomization to progression or death, whichever comes first, assessed up to 27 months","title":"Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment","type":"PRIMARY","unitOfMeasure":"Percent event-free probability in PFS"}