{"groups":[{"description":"Study drug was given by continuous oral daily dosing of two 5 mg tablets.","id":"FG000","title":"Everolimus"},{"description":"Placebo was given by continuous oral daily dosing of two 5 mg tablets.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Abnormal lab value (s)"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"39"}],"type":"STARTED"},{"achievements":[{"comment":"Completed = Completed the Core phase \\& moved to Extension phase","groupId":"FG000","numSubjects":"72"},{"comment":"Completed = 1st received Placebo in the Core phase, switched to Everolimus in Extension phase","groupId":"FG001","numSubjects":"26"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"13"}],"type":"NOT COMPLETED"}],"title":"Double-blind Period (Core Phase)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Abnormal lab value (s)"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"New treatment"}],"milestones":[{"achievements":[{"comment":"112 pts had Everolimus during core and/or extension (6 from placebo did not switch to Eve. in ext.)","groupId":"FG000","numSubjects":"112"},{"comment":"Placebo randomized patients who switched to Everolimus are reported in \"Everolimus\" arm.","groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"comment":"Treatment duration completed as per protocol","groupId":"FG000","numSubjects":"83"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Everolimus Period (Core or Extension)"}],"preAssignmentDetails":"The trial had a 2:1 randomization in favor of the everolimus arm. 118 patients were randomized to the core phase of the study. 112 patients received everolimus during core and/or extension phase.","recruitmentDetails":"A multicenter trial conducted at 24 sites in 11 countries. As the primary analysis of the core phase of the study favored everolimus over placebo, an open-label extension phase started: patients randomized in placebo were offered to switch on everolimus and those still receiving everolimus at the end of the core phase could continue the treatment."}