{"groups":[{"description":"CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG000","title":"Cohort A: CP-CML R-I"},{"description":"CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG001","title":"Cohort B: CP-CML With T315I Mutation"},{"description":"AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG002","title":"Cohort C: AP-CML R-I"},{"description":"AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG003","title":"Cohort D: AP-CML With T315I Mutation"},{"description":"BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG004","title":"Cohort E: BP-CML/Ph+ ALL R-I"},{"description":"BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG005","title":"Cohort F: BP-CML or Ph+ ALL With T315I Mutation"},{"description":"Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).","id":"FG006","title":"Unassigned to Cohorts A-F"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"7"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Non-compliance with Study Drug"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"23"},{"groupId":"FG005","numSubjects":"27"},{"groupId":"FG006","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"2"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"0"}],"type":"Reason Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"203"},{"groupId":"FG001","numSubjects":"64"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"18"},{"groupId":"FG004","numSubjects":"48"},{"groupId":"FG005","numSubjects":"46"},{"groupId":"FG006","numSubjects":"5"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"203"},{"groupId":"FG001","numSubjects":"64"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"18"},{"groupId":"FG004","numSubjects":"48"},{"groupId":"FG005","numSubjects":"46"},{"groupId":"FG006","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were assigned to 1 of 6 cohorts: chronic myeloid leukemia (CML) in chronic (CP), accelerated (AP), or blast phase (BP), or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who were resistant or intolerant (R-I) to either dasatinib or nilotinib or had (T)hreonine-315-(I)soleucine (T315I) mutation.","recruitmentDetails":"Participants took part in the study at 66 investigative sites in the Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Republic of Korea, Singapore, Spain, Sweden, the United Kingdom and the United States from 30 September 2010 to 17 January 2019."}