{"classes":[{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"20.0","upperLimit":"112.0","value":"56.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"88"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"4.0","upperLimit":"121.0","value":"53.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"94"}],"units":"Participants"}],"title":"Week 18"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"20.0","upperLimit":"111.0","value":"55.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"94"}],"units":"Participants"}],"title":"Week 42"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"20.0","upperLimit":"112.0","value":"57.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"88"}],"units":"Participants"}],"title":"Week 66"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"20.0","upperLimit":"150.0","value":"49.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"66"}],"units":"Participants"}],"title":"Week 90"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"239"}],"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"},{"description":"Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.","id":"OG003","title":"Everolimus Long Term Evaluation (LTE)"}],"paramType":"MEDIAN","populationDescription":"The Long Term Evaluation (LTE) efficacy set consists of all patients who received at least one dose of everolimus and had at least one efficacy assessment while on everolimus.","reportingStatus":"POSTED","timeFrame":"Baseline, Weeks 18, 42, 66 and 90","title":"Long Term Evaluation: Effect of Everolimus Over Time in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score","type":"SECONDARY","unitOfMeasure":"scores on a scale"}