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NCT00105001 · BASELINE

Baseline characteristics

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2019-10-30

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
      70
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      69
    4. group Id
      BG003
      value
      210
    units
    Participants
groups
  1. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    id
    BG000
    title
    Arm I (MMF and Tacrolimus)
  2. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    id
    BG001
    title
    Arm II (MMF and Tacrolimus Alternate Schedule)
  3. description
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    id
    BG002
    title
    Arm III (MMF, Tacrolimus, and Sirolimus)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          49
        4. group Id
          BG003
          value
          156
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          52
        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
          26
          upper Limit
          74
          value
          60
        2. group Id
          BG001
          lower Limit
          13
          upper Limit
          72
          value
          60
        3. group Id
          BG002
          lower Limit
          15
          upper Limit
          75
          value
          60
        4. group Id
          BG003
          lower Limit
          13
          upper Limit
          75
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          82
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          128
        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
          59
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          176
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          19
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      70
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      69
    4. group Id
      BG003
      value
      210
    units
    Participants
groups
  1. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    id
    BG000
    title
    Arm I (MMF and Tacrolimus)
  2. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    id
    BG001
    title
    Arm II (MMF and Tacrolimus Alternate Schedule)
  3. description
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    id
    BG002
    title
    Arm III (MMF, Tacrolimus, and Sirolimus)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          49
        4. group Id
          BG003
          value
          156
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          52
        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
          26
          upper Limit
          74
          value
          60
        2. group Id
          BG001
          lower Limit
          13
          upper Limit
          72
          value
          60
        3. group Id
          BG002
          lower Limit
          15
          upper Limit
          75
          value
          60
        4. group Id
          BG003
          lower Limit
          13
          upper Limit
          75
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          82
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          128
        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
          59
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          176
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          19
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice