{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.913","upperLimit":"1.014","value":"0.962"},{"groupId":"OG001","lowerLimit":"1.016","upperLimit":"1.208","value":"1.108"},{"groupId":"OG002","lowerLimit":"1.037","upperLimit":"1.153","value":"1.093"},{"groupId":"OG003","lowerLimit":"1.017","upperLimit":"1.127","value":"1.071"},{"groupId":"OG004","lowerLimit":"0.872","upperLimit":"1.108","value":"0.983"},{"groupId":"OG005","lowerLimit":"0.913","upperLimit":"1.291","value":"1.086"},{"groupId":"OG006","lowerLimit":"0.936","upperLimit":"1.523","value":"1.194"},{"groupId":"OG007","lowerLimit":"0.974","upperLimit":"1.163","value":"1.065"},{"groupId":"OG008","lowerLimit":"0.971","upperLimit":"1.089","value":"1.028"},{"groupId":"OG009","lowerLimit":"0.886","upperLimit":"1.034","value":"0.957"},{"groupId":"OG010","lowerLimit":"0.874","upperLimit":"1.190","value":"1.020"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"37"},{"groupId":"OG004","value":"34"},{"groupId":"OG005","value":"31"},{"groupId":"OG006","value":"31"},{"groupId":"OG007","value":"17"},{"groupId":"OG008","value":"12"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"7"}],"units":"Participants"}],"description":"Impact of everolimus on AED concentrations at trough. Pre-dose plasma samples to measure AED concentrations were measured at at Visits 1 (Screening), 2 (Baseline), 3, and 5. Effects of everolimus on the exposure of antiepileptic drugs was assessed by comparing the anti-epileptic drug concentrations at Visits 1 and 2 (AEDs alone) and at Visits 3 and 5 (AEDs plus everolimus).","dispersionType":"90% Confidence Interval","groups":[{"description":"Antiepileptic drug","id":"OG000","title":"Valporic Acid"},{"description":"antiepileptic drug","id":"OG001","title":"Carbamazepine"},{"description":"antiepileptic drug","id":"OG002","title":"Clobazam"},{"description":"antiepileptic drug","id":"OG003","title":"N-desmethylclobazam"},{"description":"antiepileptic drug","id":"OG004","title":"Topiramate"},{"description":"antiepileptic drug","id":"OG005","title":"TRI477"},{"description":"antiepileptic drug","id":"OG006","title":"TRI476"},{"description":"antiepileptic drug","id":"OG007","title":"Clonazepam"},{"description":"antiepileptic drug","id":"OG008","title":"Zonisamide"},{"description":"antiepileptic drug","id":"OG009","title":"Phenobarbital"},{"description":"antiepileptic drug","id":"OG010","title":"Phenytoin"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set and Long-term Evaluation (LTE) Safety Set was defined as: 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":"Baseline, Weeks 1 & 3","title":"Core Phase: Impact of Everolimus on Anti-epileptic Drugs (AEDs) Concentrations","type":"SECONDARY","unitOfMeasure":"ng/mL"}