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NCT00003389 · BASELINE

Baseline characteristics

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma · 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
      395
    2. group Id
      BG001
      value
      399
    3. group Id
      BG002
      value
      794
    units
    Participants
groups
  1. description
    Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
    id
    BG000
    title
    Arm A (ABVD)
  2. description
    Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide \[375 mg/m²\] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
    id
    BG001
    title
    Arm B (Stanford V)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          83
          value
          33
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          83
          value
          33
        3. group Id
          BG002
          lower Limit
          16
          upper Limit
          83
          value
          33
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          187
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          369
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          425
        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
          46
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          349
        2. group Id
          BG001
          value
          349
        3. group Id
          BG002
          value
          698
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Eligible patients are included in the primary analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      395
    2. group Id
      BG001
      value
      399
    3. group Id
      BG002
      value
      794
    units
    Participants
groups
  1. description
    Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
    id
    BG000
    title
    Arm A (ABVD)
  2. description
    Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide \[375 mg/m²\] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
    id
    BG001
    title
    Arm B (Stanford V)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          83
          value
          33
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          83
          value
          33
        3. group Id
          BG002
          lower Limit
          16
          upper Limit
          83
          value
          33
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          187
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          369
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          425
        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
          46
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          349
        2. group Id
          BG001
          value
          349
        3. group Id
          BG002
          value
          698
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Eligible patients are included in the primary analysis.

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Preserved source evidence · Not medical advice