{"classes":[{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"6.87","upperLimit":"10.95","value":"8.93"}]}],"title":"By doubling the time-normalized Cmin (log scale)"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"46.37","upperLimit":"51.15","value":"48.82"}]}],"title":"By reporting half the seizure freq. at baseline"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"4.53","upperLimit":"8.27","value":"6.42"}]}],"title":"By adding 12 weeks on treatmen"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"358"}],"units":"Participants"}],"description":"A repeated measures analysis considering fixed 2-week intervals and including the level of exposure (time-normalized Cmin values), the time on-treatment and the seizure frequency at baseline quantified the estimated percentage change over 2 weeks in seizure frequency associated with a double exposure to everolimus, 15 days more on treatment and half the seizure frequency at baseline. A positive percentage change means a reduction in seizure frequency whereas a negative percentage change means an increase in seizure frequency.","dispersionType":"95% Confidence Interval","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":"MEAN","populationDescription":"Confirmed PK Sample Set from all everolimus-treated patients in the Longer-term Evaluation (LTE) Safety Set, was defined as follows: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose","reportingStatus":"POSTED","timeFrame":"During everolimus treatment from start of everolimus up to the end of the extension phase, an average of 1.7 year","title":"Long Term Evaluation: Relationship Between Seizure Frequency and Time-normalized Everolimus Concentration at Trough (Cmin,TN) - Repeated Measures Analysis","type":"SECONDARY","unitOfMeasure":"% change over 2-wk in seizures freq."}