{"analyses":[{"ciLowerLimit":"-10.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.2","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"-2.1"},{"ciLowerLimit":"-7.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.6","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"0.4"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43","upperLimit":"86","value":"56.1"},{"groupId":"OG001","lowerLimit":"35","upperLimit":"81","value":"58.8"},{"groupId":"OG002","lowerLimit":"13","upperLimit":"88","value":"59.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"14"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47","upperLimit":"89","value":"58.5"},{"groupId":"OG001","lowerLimit":"46","upperLimit":"74","value":"60.7"},{"groupId":"OG002","lowerLimit":"29","upperLimit":"87","value":"65.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"title":"End of Core Phase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-11","upperLimit":"11","value":"4.7"},{"groupId":"OG001","lowerLimit":"-13","upperLimit":"38","value":"5.8"},{"groupId":"OG002","lowerLimit":"-18","upperLimit":"25","value":"7.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"title":"Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"33"}],"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 for Adolescents-48 (QOLIE-AD-48) is a survey of health-related quality of life for adolescents 11 to 18 years of age with epilepsy. The QOLIE-AD-48 is completed by the patient. It contains 48 items which assess 8 subscales. Scores range from 0-100, with higher scores corresponding to improved QoL. The overall quality of life score is obtained by summing a linear combination of the 8 subscale scores, where each subscale is multiplied by a relative weight that is provided in the original publication.","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-AD-48 Overall Quality-of-life Score for Patients >=11 to 18 Years","type":"SECONDARY","unitOfMeasure":"scores on a scale"}