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NCT00513474 · BASELINE

Baseline characteristics

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant · Source last updated 2017-05-25

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
      21
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      42
    units
    Participants
groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    id
    BG000
    title
    Rasburicase Group
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    id
    BG001
    title
    Control Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          20
          upper Limit
          59
          value
          42.9
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          55
          value
          45
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          59
          value
          44
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          23
        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
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      MRD: Cyclsporine + Methotrexate
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      MRD: Tacrolimus + Methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      MUD: Tacrolimus + Methotrexate + ATG
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      MUD: Tacrolimus + Methotrexate
    description
    Participants received GVHD prophylaxis at the investigator's discretion. MRD=matched related donor. MUD=matched unrelated donor. ATG=antithymocyte globulin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Graft-Versus-Host Disease (GVHD) Prophylaxis Intervention
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          28
      title
      Busulfan + Cyclophosphamide
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Busulfan + Fludarabine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Total Body Irradiation + Cyclophosphamide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Conditioning Protocol Interventions
    unit Of Measure
    Participants
population Description
Intent-to-treat participants included in the analyses.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      42
    units
    Participants
groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    id
    BG000
    title
    Rasburicase Group
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    id
    BG001
    title
    Control Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          20
          upper Limit
          59
          value
          42.9
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          55
          value
          45
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          59
          value
          44
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          23
        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
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      MRD: Cyclsporine + Methotrexate
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      MRD: Tacrolimus + Methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      MUD: Tacrolimus + Methotrexate + ATG
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      MUD: Tacrolimus + Methotrexate
    description
    Participants received GVHD prophylaxis at the investigator's discretion. MRD=matched related donor. MUD=matched unrelated donor. ATG=antithymocyte globulin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Graft-Versus-Host Disease (GVHD) Prophylaxis Intervention
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          28
      title
      Busulfan + Cyclophosphamide
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Busulfan + Fludarabine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Total Body Irradiation + Cyclophosphamide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Conditioning Protocol Interventions
    unit Of Measure
    Participants
population Description
Intent-to-treat participants included in the analyses.

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

Preserved source evidence · Not medical advice