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NCT01499147 · BASELINE

Baseline characteristics

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies · Source last updated 2018-11-08

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
      18
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      30
    units
    Participants
groups
  1. description
    All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
    id
    BG000
    title
    Arm 1
  2. description
    All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
    id
    BG001
    title
    Arm 2
  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
          61
          value
          34
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          61
          value
          49
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          61
          value
          42.5
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        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
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      18
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      30
    units
    Participants
groups
  1. description
    All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
    id
    BG000
    title
    Arm 1
  2. description
    All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
    id
    BG001
    title
    Arm 2
  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
          61
          value
          34
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          61
          value
          49
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          61
          value
          42.5
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        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
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice