{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.24","value":"27.52"},{"groupId":"OG001","spread":"16.202","value":"27.74"}]}],"title":"Week 6 (n= 37, 47)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.76","value":"38.7"},{"groupId":"OG001","spread":"14.662","value":"39.25"}]}],"title":"Week 24 (n= 11, 13)"},{"categories":[{"measurements":[{"comment":"Only one participant was evaluable, so value was not available.","groupId":"OG000","spread":"NA","value":"23.2"},{"groupId":"OG001","spread":"28.884","value":"49.73"}]}],"title":"Week 48 (n= 1, 3)"},{"categories":[{"measurements":[{"comment":"No participant was evaluable, so value was not available.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"21.902","value":"31.63"}]}],"title":"Week 96 (n= 0, 6)"},{"categories":[{"measurements":[{"comment":"No participant was evaluable, so value was not available.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"11.908","value":"26.33"}]}],"title":"Week 144 (n= 0, 6)"},{"categories":[{"measurements":[{"comment":"No participant was evaluable, so value was not available.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"No participant was evaluable, so value was not available.","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Week 240 (n= 0, 0)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"description":"The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as \\< 20 ng/mL, 20-50 ng/mL, and \\> 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.","dispersionType":"Standard Deviation","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 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":"OG001","title":"Everolimus (Extension Period)"}],"paramType":"MEAN","populationDescription":"The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.","reportingStatus":"POSTED","timeFrame":"2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240","title":"Everolimus Blood Concentration (C2h) at 2 Hours Post Dose","type":"SECONDARY","unitOfMeasure":"ng/mL"}