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NCT01812252 · BASELINE

Baseline characteristics

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15

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
      25
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      50
    units
    Participants
groups
  1. description
    Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies
    id
    BG000
    title
    Arm A (Decitabine or Azacitidine)
  2. description
    Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies
    id
    BG001
    title
    Arm B (Induction-like Chemotherapy Regimen)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27.3
          upper Limit
          78.4
          value
          59.9
        2. group Id
          BG001
          lower Limit
          31.9
          upper Limit
          73.6
          value
          60.7
        3. group Id
          BG002
          lower Limit
          27.3
          upper Limit
          78.4
          value
          60.3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          44
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Eligible patients will be randomized in a 1:1 fashion. The primary outcome will be analyzed on an intention-to-treat basis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      50
    units
    Participants
groups
  1. description
    Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies
    id
    BG000
    title
    Arm A (Decitabine or Azacitidine)
  2. description
    Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies
    id
    BG001
    title
    Arm B (Induction-like Chemotherapy Regimen)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27.3
          upper Limit
          78.4
          value
          59.9
        2. group Id
          BG001
          lower Limit
          31.9
          upper Limit
          73.6
          value
          60.7
        3. group Id
          BG002
          lower Limit
          27.3
          upper Limit
          78.4
          value
          60.3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          44
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Eligible patients will be randomized in a 1:1 fashion. The primary outcome will be analyzed on an intention-to-treat basis.

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

Preserved source evidence · Not medical advice