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NCT00408681 · BASELINE

Baseline characteristics

Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant · Source last updated 2017-03-07

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
      20
    units
    Participants
groups
  1. description
    Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Treated Patients
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          63
          value
          49.5
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Non-Hodgkin lymphoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Acute myeloid leukemia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Multiple myeloma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Chronic myeloid leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Acute lymphoid leukemia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Myelodysplastic syndrome
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Aplastic anemia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Paroxysmal nocturnal hemoglobinuria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Chronic lymphocytic leukemia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Indication for transplantation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Myeloablative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Nonmyeloablative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of pretransplant conditioning regimen
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Cyclosporine and mycophenolate mofetil (MMF)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Tacrolimus and methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cyclophosphamide, tacrolimus, MMF
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Tacrolimus and mycophenolate mofeftil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Graft-versus-host disease (GVHD) prophylaxis regimen
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Duodenum alone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Colon alone
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Duodenum and colon
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mucosal denudation
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Tacrolimus
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Cyclosporine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Mycophenolate mofetil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Agents given to prevent GVHD at the time of enrollment
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Infliximab
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Rabbit anti-thymocyte globulin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Horse anti-thymocyte globulin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Extracorporeal photopheresis
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Mesenchymal stem cells
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Mycophenolate mofetil
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Tacrolimus
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Sirolimus
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cyclosporine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Agents given to treat GVHD more than 3 days before enrollment in the study
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          215
          value
          90
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Interval from transplantation to start of study product administration
    unit Of Measure
    days
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    units
    Participants
groups
  1. description
    Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Treated Patients
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          63
          value
          49.5
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Non-Hodgkin lymphoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Acute myeloid leukemia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Multiple myeloma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Chronic myeloid leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Acute lymphoid leukemia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Myelodysplastic syndrome
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Aplastic anemia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Paroxysmal nocturnal hemoglobinuria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Chronic lymphocytic leukemia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Indication for transplantation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Myeloablative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Nonmyeloablative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of pretransplant conditioning regimen
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Cyclosporine and mycophenolate mofetil (MMF)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Tacrolimus and methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cyclophosphamide, tacrolimus, MMF
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Tacrolimus and mycophenolate mofeftil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Graft-versus-host disease (GVHD) prophylaxis regimen
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Duodenum alone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Colon alone
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Duodenum and colon
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mucosal denudation
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Tacrolimus
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Cyclosporine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Mycophenolate mofetil
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Agents given to prevent GVHD at the time of enrollment
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Infliximab
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Rabbit anti-thymocyte globulin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Horse anti-thymocyte globulin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Extracorporeal photopheresis
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Mesenchymal stem cells
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Mycophenolate mofetil
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Tacrolimus
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Sirolimus
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cyclosporine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Agents given to treat GVHD more than 3 days before enrollment in the study
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          215
          value
          90
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Interval from transplantation to start of study product administration
    unit Of Measure
    days

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Preserved source evidence · Not medical advice