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NCT01522976 · BASELINE

Baseline characteristics

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia · Source last updated 2026-09-09

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
      93
    2. group Id
      BG001
      value
      92
    3. group Id
      BG002
      value
      92
    4. group Id
      BG003
      value
      277
    units
    Participants
groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    BG000
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    BG001
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    BG002
    title
    Arm 3: Azacitidine/Vorinostat
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51.29
          upper Limit
          86.68
          value
          70.81
        2. group Id
          BG001
          lower Limit
          42.69
          upper Limit
          88.96
          value
          69.67
        3. group Id
          BG002
          lower Limit
          28.69
          upper Limit
          93.01
          value
          70.36
        4. group Id
          BG003
          lower Limit
          28.69
          upper Limit
          93.01
          value
          70.18
    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
          32
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          192
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          249
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Analysis includes eligible patients only.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      93
    2. group Id
      BG001
      value
      92
    3. group Id
      BG002
      value
      92
    4. group Id
      BG003
      value
      277
    units
    Participants
groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    BG000
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    BG001
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    BG002
    title
    Arm 3: Azacitidine/Vorinostat
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51.29
          upper Limit
          86.68
          value
          70.81
        2. group Id
          BG001
          lower Limit
          42.69
          upper Limit
          88.96
          value
          69.67
        3. group Id
          BG002
          lower Limit
          28.69
          upper Limit
          93.01
          value
          70.36
        4. group Id
          BG003
          lower Limit
          28.69
          upper Limit
          93.01
          value
          70.18
    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
          32
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          192
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          249
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Analysis includes eligible patients only.

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Preserved source evidence · Not medical advice