{"groups":[{"description":"Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.","id":"FG000","title":"Gilteritinib"},{"description":"Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\\^2 daily by IV for 5 days, etoposide 100 mg/m\\^2 daily by IV for 5 days and cytarabine 1000 mg/m\\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).","id":"FG001","title":"Salvage Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"76"},{"groupId":"FG001","numSubjects":"16"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"31"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"10"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"2"}],"type":"Disease relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"24"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"11"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"5"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"247"},{"groupId":"FG001","numSubjects":"124"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"109"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"19"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"247"},{"groupId":"FG001","numSubjects":"105"}],"type":"NOT COMPLETED"}],"title":"Randomization Period: Up to 3 Years"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"65"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"1"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"73"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"73"}],"type":"NOT COMPLETED"}],"title":"Long Term Follow up: up to 3 Years"}],"preAssignmentDetails":"Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator preselected a salvage chemotherapy for each participant. The randomization was stratified by response to first-line AML therapy and preselected salvage chemotherapy. Treatment was given over continuous 28-day cycles.","recruitmentDetails":"Participants were recruited from approximately 140 centers in North America, Europe, Asia and the rest of the world and randomized in a 2:1 ratio to receive gilteritinib or salvage chemotherapy. Participants had FMS-like tyrosine kinase 3 (FLT3) mutations and relapsed or refractory acute myeloid leukemia (AML) after first-line therapy."}