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NCT01527045 · BASELINE

Baseline characteristics

Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies · Source last updated 2020-01-02

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
      30
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      47
    units
    Participants
groups
  1. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG000
    title
    Primary - Reg A (Flu/TBI)
  2. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG001
    title
    Primary - Reg B (TBI Alone)
  3. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG002
    title
    Adjunct
  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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          26
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          21
        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
          26.8
          upper Limit
          79.5
          value
          65.4
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          66.9
          value
          54
        3. group Id
          BG002
          lower Limit
          53.6
          upper Limit
          74.5
          value
          62.35
        4. group Id
          BG003
          lower Limit
          26.8
          upper Limit
          79.5
          value
          64.1
    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
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          31
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          46
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          39
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          47
      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
      30
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      47
    units
    Participants
groups
  1. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG000
    title
    Primary - Reg A (Flu/TBI)
  2. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG001
    title
    Primary - Reg B (TBI Alone)
  3. description
    NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
    id
    BG002
    title
    Adjunct
  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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          26
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          21
        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
          26.8
          upper Limit
          79.5
          value
          65.4
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          66.9
          value
          54
        3. group Id
          BG002
          lower Limit
          53.6
          upper Limit
          74.5
          value
          62.35
        4. group Id
          BG003
          lower Limit
          26.8
          upper Limit
          79.5
          value
          64.1
    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
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          31
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          46
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          39
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          47
      title
      United States
    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