{"groups":[{"description":"Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.","id":"FG000","title":"Cohort 1"},{"description":"Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.","id":"FG001","title":"Cohort 2"},{"description":"Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.","id":"FG002","title":"Cohort 3"},{"description":"Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.","id":"FG003","title":"PK Sub-Study"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"0"}],"type":"Reached 18 years of age and transitioned to commercial drug"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"0"}],"type":"Administrative Reason By Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"}],"type":"Failure to Meet Study Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Non-compliance with Study Drug"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"}],"type":"Maximum Clinical Benefit"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"0"}],"type":"Participant Request to Discontinue Study Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"}],"type":"Study Drug Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Not Reported"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Site Closed"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"84"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"84"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"On Treatment"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"comment":"4 Participants Joined PK Sub-study from Cohort 3","groupId":"FG003","numSubjects":"7"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"comment":"All 7 participants Completed. 4 participants who joined from cohort 3 re-joined Cohort 3 after PK Sub-study completed.","groupId":"FG003","numSubjects":"7"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"PK Sub-Study"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"0"}],"type":"Reason Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"}],"type":"Missing - Administrative Reasons in Russia"}],"milestones":[{"achievements":[{"comment":"Not all participants who discontinued treatment entered the follow-up period","groupId":"FG000","numSubjects":"21"},{"comment":"Not all participants who discontinued treatment entered the follow-up period","groupId":"FG001","numSubjects":"12"},{"comment":"Not all participants who discontinued treatment entered the follow-up period","groupId":"FG002","numSubjects":"47"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Follow-Up"}],"preAssignmentDetails":"The PK sub-study analysis is not part of the pre-specified primary and secondary outcome measures.","recruitmentDetails":"Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA)."}