{"analyses":[{"ciLowerLimit":"1.16","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.20","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.008","paramType":"Odds Ratio (OR)","paramValue":"2.21","statisticalMethod":"Bonferroni-Holm"},{"ciLowerLimit":"2.10","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.32","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"3.93","statisticalMethod":"Bonferroni-Holm"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.3","upperLimit":"37.3","value":"28.2"},{"groupId":"OG001","lowerLimit":"31.5","upperLimit":"49.0","value":"40.0"},{"groupId":"OG002","lowerLimit":"9.2","upperLimit":"22.8","value":"15.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"description":"Comparison of response rates in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. Response means at least a 50% reduction from baseline in partial-onset seizure frequency during the maintenance period of the core phase.","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":"NUMBER","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: European Medicine Agency (EMA): Seizure Frequency Response Rate","type":"PRIMARY","unitOfMeasure":"Percentage of responders"}