{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Clopper-Pearson","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.8","upperLimit":"53.4","value":"41.8"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"9.0","value":"0"},{"groupId":"OG002","lowerLimit":"48.3","upperLimit":"67.3","value":"58.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"112"}],"units":"Participants"}],"description":"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \\> 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.\n\nFor the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.","dispersionType":"95% Confidence Interval","groups":[{"description":"Study drug was given by continuous oral daily dosing of two 5 mg tablets.","id":"OG000","title":"Everolimus Randomized (Core Period)"},{"description":"Placebo was given by continuous oral daily dosing of two 5 mg tablets.","id":"OG001","title":"Placebo Randomized (Core Period)"},{"description":"Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.","id":"OG002","title":"Everolimus (Core and/or Extension Period)"}],"paramType":"NUMBER","populationDescription":"The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.","reportingStatus":"POSTED","timeFrame":"From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years","title":"Angiomyolipoma Response Rate as Per Central Radiology Review","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}