{"groups":[{"description":"Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"FG000","title":"Phase 1: Blinatumomab 5 µg/m²/Day"},{"description":"Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"FG001","title":"Phase 1: Blinatumomab 15 µg/m²/Day"},{"description":"Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"FG002","title":"Phase 1: Blinatumomab 30 µg/m²/Day"},{"description":"Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.","id":"FG003","title":"Phase 1: Blinatumomab 15/30 µg/m²/Day"},{"description":"PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.","id":"FG004","title":"Phase 1: Blinatumomab 5/15 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.","id":"FG005","title":"Phase 2: Blinatumomab 5/15 µg/m²/Day"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"3"}],"type":"Hematopoietic Stem Cell Transplantation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"18"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"5"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"4"}],"type":"Change of Chemotherapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"}],"type":"Disease Relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"8"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}],"type":"Withdrawal by Parent/Guardian"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"26"},{"groupId":"FG005","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"comment":"Completed 5 cycles","groupId":"FG000","numSubjects":"0"},{"comment":"Completed 5 cycles","groupId":"FG001","numSubjects":"1"},{"comment":"Completed 5 cycles","groupId":"FG002","numSubjects":"0"},{"comment":"Completed 5 cycles","groupId":"FG003","numSubjects":"1"},{"comment":"Completed 5 cycles","groupId":"FG004","numSubjects":"0"},{"comment":"Completed 5 cycles","groupId":"FG005","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"26"},{"groupId":"FG005","numSubjects":"41"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The Phase 1 part of the study comprised 2 parts:\n\n* a dose evaluation/escalation part in patients aged 2 to 17 years to define the recommended phase 2 dose of blinatumomab (4 arms),\n* a pharmacokinetic (PK) expansion part in patients less than 18 years.\n\nThe Phase 2 efficacy part enrolled patients at the recommended dose determined in phase 1.","recruitmentDetails":"The study was conducted in 26 centers in Germany, France, Italy, the Netherlands, the United Kingdom, and the United States of America. Results are reported for the primary analysis with a data cut-off date of 12 January 2015."}