{"groups":[{"description":"The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.","id":"FG000","title":"RAD001 +BSC"},{"description":"Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.","id":"FG001","title":"Placebo + BSC / RAD001"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Abnormal Laboratory Value"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"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":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"124"}],"type":"Disease Progression"}],"milestones":[{"achievements":[{"comment":"Started indicates randomized (FAS) and treated","groupId":"FG000","numSubjects":"277"},{"groupId":"FG001","numSubjects":"139"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"4"}],"type":"Ongoing"},{"achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"2"}],"type":"Completed Double Blind Treatment"},{"achievements":[{"comment":"Patients ongoing/completed double blind phase had option entering extension phase continuing RAD001.","groupId":"FG000","numSubjects":"75"},{"comment":"All patients ongoing/completed/not completed in core had option to enter extension taking RAD001.","groupId":"FG001","numSubjects":"6"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"202"},{"groupId":"FG001","numSubjects":"133"}],"type":"NOT COMPLETED"}],"title":"Core Phase Double Blind (15 Months)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"19"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Abnormal Laboratory Values"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Abnormal Test Procedures"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"10"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"78"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Patient no longer required study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Final Primary Analysis"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"67"},{"comment":"Patients on placebo in core received RAD001 in extension phase.","groupId":"FG001","numSubjects":"111"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"67"},{"groupId":"FG001","numSubjects":"111"}],"type":"NOT COMPLETED"}],"title":"Extension Phase - Open Label (45 Months)"}],"preAssignmentDetails":"Core period was terminated due to early achievements of efficacy targets and patients who were receiving study drug and patients receiving placebo in double blind phase had option to continue into the extension phase to receive open label RAD001."}