{"groups":[{"description":"Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"FG000","title":"CML-CP With Prior Imatinib Only"},{"description":"Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"FG001","title":"CML-AP With Prior Imatinib Only"},{"description":"Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"FG002","title":"CML-CP"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"215"},{"groupId":"FG001","numSubjects":"122"},{"groupId":"FG002","numSubjects":"34"}],"type":"Discontinued in core study without entering the extension study"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Abnormal laboratory values"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient withdrew consent"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"321"},{"groupId":"FG001","numSubjects":"137"},{"groupId":"FG002","numSubjects":"49"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"15"}],"type":"Entered Extension Study"},{"achievements":[{"groupId":"FG000","numSubjects":"67"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"254"},{"groupId":"FG001","numSubjects":"129"},{"groupId":"FG002","numSubjects":"41"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 507 participants were randomized in the core study, out of which 136 participants entered the extension study.","recruitmentDetails":"The study was conducted at 100 centers in 22 countries."}