{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.79","upperLimit":"3.02","value":"2.86"},{"groupId":"OG001","lowerLimit":"2.79","upperLimit":"3.19","value":"2.89"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. 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; no kidney increases in volume \\> 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.\n\nFor the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition 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":"Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.","id":"OG001","title":"Everolimus (Core and/or Extension Period)"}],"paramType":"MEDIAN","populationDescription":"The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.","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":"Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response","type":"SECONDARY","unitOfMeasure":"months"}