{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.2","upperLimit":"53.9","value":"41.7"},{"groupId":"OG001","lowerLimit":"2.9","upperLimit":"24.8","value":"10.5"},{"groupId":"OG002","lowerLimit":"48.1","upperLimit":"67.7","value":"58.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"105"}],"units":"Participants"}],"description":"Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician's Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but \\< 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - \\< 50% and 6 = progressive disease, indicated worse than at baseline evaluation by \\> 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.","id":"OG000","title":"Everolimus (Core Period)"},{"description":"Participants received oral dose of placebo matching to everolimus daily.","id":"OG001","title":"Placebo (Core Period)"},{"description":"Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.","id":"OG002","title":"Everolimus (Extension Period)"}],"paramType":"NUMBER","populationDescription":"The analysis was performed in the FAS population. Here, \"Number of participants analysed\" signifies the participants assessed for skin lesion response during the study for each arm, respectively.","reportingStatus":"POSTED","timeFrame":"End of core period (Week 48), and end of extension period (up to 4 years)","title":"Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}