Skip to content
← Full study record

NCT00313586 · BASELINE

Baseline characteristics

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia · Source last updated 2017-02-02

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
      74
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      23
    5. group Id
      BG004
      value
      196
    units
    Participants
groups
  1. description
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    BG000
    title
    Arm A (Azacitidine; Non-treatment-induced Cohort)
  2. description
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    BG001
    title
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
  3. description
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    BG002
    title
    Arm A (Azacitidine; Treatment-induced Cohort)
  4. description
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    BG003
    title
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          87
          value
          72
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          86
          value
          72
        3. group Id
          BG002
          lower Limit
          54
          upper Limit
          83
          value
          68
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          81
          value
          71
        5. group Id
          BG004
          lower Limit
          25
          upper Limit
          87
          value
          71
    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
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          123
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          196
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All treated patients were included in the analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      74
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      23
    5. group Id
      BG004
      value
      196
    units
    Participants
groups
  1. description
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    BG000
    title
    Arm A (Azacitidine; Non-treatment-induced Cohort)
  2. description
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    BG001
    title
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
  3. description
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    BG002
    title
    Arm A (Azacitidine; Treatment-induced Cohort)
  4. description
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    BG003
    title
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          87
          value
          72
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          86
          value
          72
        3. group Id
          BG002
          lower Limit
          54
          upper Limit
          83
          value
          68
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          81
          value
          71
        5. group Id
          BG004
          lower Limit
          25
          upper Limit
          87
          value
          71
    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
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          123
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          196
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All treated patients were included in the analysis.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice