{"groups":[{"description":"Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.","id":"FG000","title":"Octreotide+ Everolimus"},{"description":"Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.","id":"FG001","title":"Octreotide+ Placebo Followed by Open Label Arm"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"154"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"16"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"14"}],"type":"Final Primary Analysis"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"20"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"New Cander Therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"216"},{"groupId":"FG001","numSubjects":"213"}],"type":"STARTED"},{"achievements":[{"comment":"1 patient did not provide at laest one valid post baseline safety assessment.","groupId":"FG000","numSubjects":"215"},{"comment":"1 pt randomized never took drug Another randomized did not have valid post BL safety assessment","groupId":"FG001","numSubjects":"211"}],"type":"Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"216"},{"groupId":"FG001","numSubjects":"213"}],"type":"NOT COMPLETED"}],"title":"Double Blind Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"86"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"46"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"15"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"}],"type":"Administrative Problems"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"New Cancer Therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"170"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"170"}],"type":"NOT COMPLETED"}],"title":"Open Label Phase"}],"preAssignmentDetails":"Total 429 patients were randomized to double blind phase of treatment. 170 patients moved to the Open Label Phase."}