{"analyses":[{"ciLowerLimit":"-17.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.3","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"-2.8"},{"ciLowerLimit":"-22.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.6","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"-7.7"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13","upperLimit":"64","value":"39.5"},{"groupId":"OG001","lowerLimit":"5","upperLimit":"89","value":"43.2"},{"groupId":"OG002","lowerLimit":"11","upperLimit":"83","value":"43.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"15"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11","upperLimit":"54","value":"48.6"},{"groupId":"OG001","lowerLimit":"6","upperLimit":"97","value":"37.1"},{"groupId":"OG002","lowerLimit":"26","upperLimit":"90","value":"54.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"title":"End of Core Phase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-17","upperLimit":"34","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-47","upperLimit":"20","value":"0.4"},{"groupId":"OG002","lowerLimit":"-16","upperLimit":"36","value":"5.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"title":"Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"23"}],"units":"Participants"}],"description":"Comparison of quality of life (from 3 age specific questionnaires) in the everolimus low-trough treatment arm (3-7 ng/mL), hightrough treatment arm (9-15 ng/mL) and placebo arm at the end of the core phase. The Quality of Life in Epilepsy Inventory-31-Problems (QOLIE-31-P) is a survey of health-related quality of life for adults with epilepsy. The QOLIE-31-P is completed by the patient. It contains 39 items, of which a total of 30 are used to make up 7 different subscales. Scores range from 0-100, with higher scores indicating a greater level of functioning and QoL. The overall quality of life score is obtained by summing a linear combination of the 7 subscale scores, where each subscale is multiplied by a relative weight that is obtained from the patient's answer to 7 items of this questionnaire.","dispersionType":"Full Range","groups":[{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL","id":"OG000","title":"Everolimus LT Target of 3 to 7 ng/mL"},{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL","id":"OG001","title":"Everolimus HT Target of 9 to 15 ng/mL"},{"description":"Participants were randomized to receive placebo dispersible tablets for oral suspension.","id":"OG002","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization","reportingStatus":"POSTED","timeFrame":"Baseline, Week 18","title":"Core Phase: Change From Baseline in the QOLIE-31-P Overall Quality-of-life Score for Patients Aged >=18 Years","type":"SECONDARY","unitOfMeasure":"scores on a scale"}