{"classes":[{"categories":[{"measurements":[{"comment":"Median not reached since too few number of patients with progressions (n=3).","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Upper limit not estimable due to few number of patients at this time point.","groupId":"OG001","lowerLimit":"11.07","upperLimit":"NA","value":"11.37"},{"comment":"Median not reached since too few number of patients with progressions (n=16)","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"112"}],"units":"Participants"}],"description":"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.\n\nFor the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. 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":"MEDIAN","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 about 5.7 years","title":"Time to Angiomyolipoma Progression as Per Central Radiology Review","type":"SECONDARY","unitOfMeasure":"months"}