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NCT03836209 · BASELINE

Baseline characteristics

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia · Source last updated 2026-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      90
    2. group Id
      BG001
      value
      87
    3. group Id
      BG002
      value
      177
    units
    Participants
groups
  1. description
    Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: 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
    BG000
    title
    Arm A
  2. description
    Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: 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
    BG001
    title
    Arm B
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13
          value
          50
        2. group Id
          BG001
          spread
          12
          value
          51
        3. group Id
          BG002
          spread
          13
          value
          51
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          103
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          74
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          152
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          137
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          44
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          114
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG (Eastern Cooperative Oncology Group) Performance Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        AML with Myelodysplasia-Related Changes
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          159
        title
        De Novo AML
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Therapy-Related AML
    description
    De Novo AML: AML that develops spontaneously without prior blood disorders or cancer treatments. Often associated with a comparatively better prognosis Therapy-Related AML (t-AML): AML that arises as a result of previous chemotherapy or radiation therapy. Generally considered a higher-risk category AML with Myelodysplasia-Related Changes (AML-MRC): AML that originates from or shows features of prior myelodysplastic syndromes or dysplasia. Also associated with a worse prognosis compared to De Novo AML
    param Type
    COUNT_OF_PARTICIPANTS
    title
    AML Category
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        AML related to previous chemotherapy or radiation
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          68
        title
        AML with certain genetic abnormalities
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        AML with myelodysplasia-related changes
      4. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          100
        title
        AML not otherwise specified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    WHO Classification
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      90
    2. group Id
      BG001
      value
      87
    3. group Id
      BG002
      value
      177
    units
    Participants
groups
  1. description
    Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: 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
    BG000
    title
    Arm A
  2. description
    Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: 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
    BG001
    title
    Arm B
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13
          value
          50
        2. group Id
          BG001
          spread
          12
          value
          51
        3. group Id
          BG002
          spread
          13
          value
          51
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          103
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          74
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          152
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          137
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          44
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          114
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG (Eastern Cooperative Oncology Group) Performance Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        AML with Myelodysplasia-Related Changes
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          159
        title
        De Novo AML
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Therapy-Related AML
    description
    De Novo AML: AML that develops spontaneously without prior blood disorders or cancer treatments. Often associated with a comparatively better prognosis Therapy-Related AML (t-AML): AML that arises as a result of previous chemotherapy or radiation therapy. Generally considered a higher-risk category AML with Myelodysplasia-Related Changes (AML-MRC): AML that originates from or shows features of prior myelodysplastic syndromes or dysplasia. Also associated with a worse prognosis compared to De Novo AML
    param Type
    COUNT_OF_PARTICIPANTS
    title
    AML Category
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        AML related to previous chemotherapy or radiation
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          68
        title
        AML with certain genetic abnormalities
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        AML with myelodysplasia-related changes
      4. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          100
        title
        AML not otherwise specified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    WHO Classification
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice