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NCT01572662 · BASELINE

Baseline characteristics

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning · Source last updated 2023-06-29

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
      49
    2. group Id
      BG001
      value
      150
    3. group Id
      BG002
      value
      199
    units
    Participants
groups
  1. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
    id
    BG000
    title
    Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
  2. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
    id
    BG001
    title
    Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          131
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          67
        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
          value
          13
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          127
        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
          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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          182
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          198
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Saudi Arabia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      49
    2. group Id
      BG001
      value
      150
    3. group Id
      BG002
      value
      199
    units
    Participants
groups
  1. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
    id
    BG000
    title
    Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
  2. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
    id
    BG001
    title
    Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          131
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          67
        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
          value
          13
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          127
        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
          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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          182
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          198
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Saudi Arabia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice