{"analyses":[{"ciLowerLimit":"-4.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.1","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"-1.1"},{"ciLowerLimit":"-2.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.3","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in least square means","paramValue":"1.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"26","upperLimit":"75","value":"52.3"},{"groupId":"OG001","lowerLimit":"26","upperLimit":"76","value":"56.5"},{"groupId":"OG002","lowerLimit":"33","upperLimit":"74","value":"55.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"55"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24","upperLimit":"79","value":"53.6"},{"groupId":"OG001","lowerLimit":"36","upperLimit":"78","value":"59.5"},{"groupId":"OG002","lowerLimit":"20","upperLimit":"77","value":"57.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"title":"End of Core Phase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-25","upperLimit":"24","value":"0.2"},{"groupId":"OG001","lowerLimit":"-19","upperLimit":"18","value":"0.0"},{"groupId":"OG002","lowerLimit":"-18","upperLimit":"28","value":"1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"47"}],"units":"Participants"}],"title":"Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"63"}],"units":"Participants"}],"description":"Comparison of quality of life in the everolimus (from 3 age specific questionnaires) low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm at the end of the core phase. The Quality of Life Childhood Epilepsy (QOLCE) questionnaire, used for patients \\< 11 years at baseline, was completed by the patient's parent or caregiver. It consists of 16 subscales (13 multi-item scales and 3 single item scales) and one overall quality-of-life score. Scores range from 0-100, with higher scores corresponding to improved QoL. The Overall Quality of Life Score is computed by adding each subscale score for each individual and then dividing by 16.","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 QOLCE Overall Quality-of-life Score for Patients <11 Years","type":"SECONDARY","unitOfMeasure":"scores on a scale"}