{"analyses":[{"ciLowerLimit":"-0.205","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"0.062","estimateComment":"Treatment Difference = Arm A - Arm B","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.366","pValueComment":"The threshold for statistical significance was p = 0.10.","paramType":"Proportion Difference","paramValue":"-0.071","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"87"}],"units":"Participants"}],"description":"FLT3 mutation negative (evaluated by polymerase chain reaction \\[PCR\\]) Composite Complete Response (CRc) \\[includes CR and CRi\\] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD.","groups":[{"description":"Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given.\n\nConsolidation: High-dose cytarabine and gilteritinib.\n\nGilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8\n\nConsolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)\n\nDaunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3\n\nSecond Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3\n\nCytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nSecond Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nConsolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles","id":"OG000","title":"Arm A"},{"description":"Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given.\n\nConsolidation: High-dose cytarabine and midostaurin.\n\nMidostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8\n\nConsolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)\n\nDaunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3\n\nSecond Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3\n\nCytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nSecond Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nConsolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles","id":"OG001","title":"Arm B"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"3 months","title":"FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction","type":"PRIMARY","unitOfMeasure":"Participants"}