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NCT00071799 · BASELINE

Baseline characteristics

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

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
      179
    2. group Id
      BG001
      value
      179
    3. group Id
      BG002
      value
      358
    units
    Participants
groups
  1. description
    Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
    id
    BG000
    title
    Azacitidine
  2. description
    Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
    id
    BG001
    title
    Conventional Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.57
          value
          68.0
        2. group Id
          BG001
          spread
          7.87
          value
          69.2
        3. group Id
          BG002
          spread
          7.73
          value
          68.6
    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
          47
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          251
        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
          177
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          352
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian/Oriental
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Hispanic
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
      title
      Refractory anemia with excess blasts (RAEB)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          123
      title
      RAEB in transformation
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      Modified chronic myelomonocytic leukemia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Acute myeloid leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Myeloproliferative disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Indeterminate
    description
    FAB classifications were determined by the Independent Review Committee
    param Type
    NUMBER
    title
    French-American-British (FAB) Classification
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          18
      title
      Intermediate risk level 1 (0.5-1.0)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          146
      title
      Intermediate risk level 2 (1.5-2.0)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          167
      title
      High risk (2.5-3.5)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      Not applicable
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Indeterminate
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The scale is 0-3.5 at .5 increments. Scores of 2.5-3.5 represent high risk which corresponds to poorer prognosis. The assessment was performed by the Independent Review Committee.
    param Type
    NUMBER
    title
    International Prognostic Scoring System (IPSS)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      Refractory anemia with excess blasts - 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          193
      title
      Refractory anemia with excess blasts - 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Chronic myelomonocytic leukemia - 1 (CMMoL-1)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      Chronic myelomonocytic leukemia - 2 (CMMoL-2)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          113
      title
      Acute myeloid leukemia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
      title
      Indeterminate
    description
    WHO classifications were determined by the Independent Review Committee
    param Type
    NUMBER
    title
    World Health Organization (WHO) Classification
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.19
          value
          1.9
        2. group Id
          BG001
          spread
          0.19
          value
          1.8
        3. group Id
          BG002
          spread
          0.19
          value
          1.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    meters squared
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.08
          value
          76.5
        2. group Id
          BG001
          spread
          13.58
          value
          74.6
        3. group Id
          BG002
          spread
          13.85
          value
          75.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      179
    2. group Id
      BG001
      value
      179
    3. group Id
      BG002
      value
      358
    units
    Participants
groups
  1. description
    Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
    id
    BG000
    title
    Azacitidine
  2. description
    Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
    id
    BG001
    title
    Conventional Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.57
          value
          68.0
        2. group Id
          BG001
          spread
          7.87
          value
          69.2
        3. group Id
          BG002
          spread
          7.73
          value
          68.6
    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
          47
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          251
        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
          177
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          352
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian/Oriental
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Hispanic
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
      title
      Refractory anemia with excess blasts (RAEB)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          123
      title
      RAEB in transformation
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      Modified chronic myelomonocytic leukemia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Acute myeloid leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Myeloproliferative disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Indeterminate
    description
    FAB classifications were determined by the Independent Review Committee
    param Type
    NUMBER
    title
    French-American-British (FAB) Classification
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          18
      title
      Intermediate risk level 1 (0.5-1.0)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          146
      title
      Intermediate risk level 2 (1.5-2.0)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          167
      title
      High risk (2.5-3.5)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      Not applicable
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Indeterminate
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The scale is 0-3.5 at .5 increments. Scores of 2.5-3.5 represent high risk which corresponds to poorer prognosis. The assessment was performed by the Independent Review Committee.
    param Type
    NUMBER
    title
    International Prognostic Scoring System (IPSS)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      Refractory anemia with excess blasts - 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          193
      title
      Refractory anemia with excess blasts - 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Chronic myelomonocytic leukemia - 1 (CMMoL-1)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      Chronic myelomonocytic leukemia - 2 (CMMoL-2)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          113
      title
      Acute myeloid leukemia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
      title
      Indeterminate
    description
    WHO classifications were determined by the Independent Review Committee
    param Type
    NUMBER
    title
    World Health Organization (WHO) Classification
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.19
          value
          1.9
        2. group Id
          BG001
          spread
          0.19
          value
          1.8
        3. group Id
          BG002
          spread
          0.19
          value
          1.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    meters squared
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.08
          value
          76.5
        2. group Id
          BG001
          spread
          13.58
          value
          74.6
        3. group Id
          BG002
          spread
          13.85
          value
          75.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms

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