{"groups":[{"description":"Patients resistant or intolerant to either imatinib or dasatinib","id":"FG000","title":"Resistant/Intolerant Ph+ CML in CP"},{"description":"Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis","id":"FG001","title":"Newly Diagnosed and Untreated Ph+ CML in First CP"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Untreated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"25"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"25"}],"type":"Treated"},{"achievements":[{"comment":"Did not receive study drug due to adverse event (AE).","groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Untreated"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"10"}],"comment":"Completed = Treatment duration is completed per protocol","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Minimum 50 pediatric patients (pts) to be enrolled in the study. At least 15 were to be Ph+ CML-CP pts resistant/intolerant to either imatinib or dasatinib, \\& at least 15 newly diagnosed Ph+ CML-CP pts. There was no requirement on the minimum number of pts to be enrolled in the Cohort of CML-AP resistant/intolerant to either imatinib or dasatinib.","recruitmentDetails":"3 cohorts were planned based on disease classification. In 1 cohort no patients (pts) were enrolled so results presented are based on 2 cohorts. 34 imatinib/dasatinib resistant/intolerant CML-CP pts \\& 25 newly diagnosed CML-CP pts were enrolled. 1 imatinib/dasatinib resistant/intolerant pt did not receive study drug \\& was excluded from analysis."}