{"analyses":[{"ciLowerLimit":"1.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"31.68","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.003","paramType":"Median Difference (Final Values)","paramValue":"15.96","statisticalMethod":"Bonferroni-Holm"},{"ciLowerLimit":"16.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"43.36","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"27.46","statisticalMethod":"Bonferroni-Holm"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.82","upperLimit":"41.88","value":"29.29"},{"groupId":"OG001","lowerLimit":"35.03","upperLimit":"48.74","value":"39.55"},{"groupId":"OG002","lowerLimit":"0.11","upperLimit":"21.71","value":"14.86"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"description":"Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where:\n\nSFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) 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"}],"paramType":"MEDIAN","populationDescription":"The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization","reportingStatus":"POSTED","timeFrame":"Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)","title":"Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency","type":"PRIMARY","unitOfMeasure":"Percentage change from baseline"}