{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.0","upperLimit":"112.0","value":"58.00"},{"groupId":"OG001","lowerLimit":"20.0","upperLimit":"102.0","value":"56.50"},{"groupId":"OG002","lowerLimit":"20.0","upperLimit":"103.0","value":"55.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"32"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.0","upperLimit":"121.0","value":"54.00"},{"groupId":"OG001","lowerLimit":"20.0","upperLimit":"111.0","value":"55.00"},{"groupId":"OG002","lowerLimit":"20.0","upperLimit":"105.0","value":"55.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"title":"End of Core Phase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-21.0","upperLimit":"15.0","value":"-1.00"},{"groupId":"OG001","lowerLimit":"-13.0","upperLimit":"15.0","value":"0.00"},{"groupId":"OG002","lowerLimit":"-12.0","upperLimit":"10.0","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"23"}],"units":"Participants"}],"title":"Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"76"}],"units":"Participants"}],"description":"Comparison of adaptive functioning using the VABS-II composite score in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Vineland II assesses an individual's development of personal independence \\& social responsibility. The questionnaire contains 433 items which assess 15 subdomains organized into the five domains of Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Behavior. The overall Adaptive Behavior Composite (ABC) score is obtained by summing the standard scores of the first four domain scores for patients aged less than 7 years, or the first 3 domain scores for patients aged 7 or older (the Maladaptive Behavior domain is optional). The ABC standard score ranges from 20 to 160 with a mean of 100 and a standard deviation of 15. Higher scores correspond to improved adaptive level. Note that 2 questionnaires with ABC scores\\<20 (data issues) were included in this analysis.","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 safety Set comprised all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).","reportingStatus":"POSTED","timeFrame":"Baseline, 18 weeks","title":"Core Phase: Change From Baseline in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score","type":"SECONDARY","unitOfMeasure":"scores on a scale"}