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NCT00651261 · BASELINE

Baseline characteristics

Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-18

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
      360
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      717
    units
    Participants
groups
  1. description
    Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
    id
    BG000
    title
    Induction and Consolidation Chemotherapy Plus Midostaurin
  2. description
    Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
    id
    BG001
    title
    Induction and Consolidation Chemotherapy Plus Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          59.8
          value
          47.1
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          60.9
          value
          48.6
        3. group Id
          BG002
          lower Limit
          18.0
          upper Limit
          60.9
          value
          47.9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          398
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          319
        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
          7
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          210
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          248
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          491
        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
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          275
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          195
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          408
        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
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          223
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          305
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Belgium
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Netherlands
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Australia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          22
      title
      Spain
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Austria
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          105
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Czech Republic
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Slovakia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          162
      title
      TKD (No ITD)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          170
        3. group Id
          BG002
          value
          341
      title
      ITD Allelic ratio <0.7
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          214
      title
      ITD Allelic ratio >=0.7
    description
    Mutations in the gene encoding the trans-membrane tyrosine kinase FLT3. FLT3 internal tandem duplications (ITD) mutation which results in a duplication between 3 and greater than 100 amino acids most commonly located in the juxtamembrane region. Tyrosine kinase domain (TKD) point mutations are the remainder of those with FLT3 mutations. FLT3 testing was done centrally.
    param Type
    NUMBER
    title
    FLT3 mutational subtype
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      360
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      717
    units
    Participants
groups
  1. description
    Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
    id
    BG000
    title
    Induction and Consolidation Chemotherapy Plus Midostaurin
  2. description
    Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
    id
    BG001
    title
    Induction and Consolidation Chemotherapy Plus Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          59.8
          value
          47.1
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          60.9
          value
          48.6
        3. group Id
          BG002
          lower Limit
          18.0
          upper Limit
          60.9
          value
          47.9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          398
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          319
        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
          7
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          210
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          248
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          491
        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
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          275
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          195
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          408
        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
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          223
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          305
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Belgium
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Netherlands
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Australia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          22
      title
      Spain
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Austria
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          105
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Czech Republic
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Slovakia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          162
      title
      TKD (No ITD)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          170
        3. group Id
          BG002
          value
          341
      title
      ITD Allelic ratio <0.7
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          214
      title
      ITD Allelic ratio >=0.7
    description
    Mutations in the gene encoding the trans-membrane tyrosine kinase FLT3. FLT3 internal tandem duplications (ITD) mutation which results in a duplication between 3 and greater than 100 amino acids most commonly located in the juxtamembrane region. Tyrosine kinase domain (TKD) point mutations are the remainder of those with FLT3 mutations. FLT3 testing was done centrally.
    param Type
    NUMBER
    title
    FLT3 mutational subtype
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice