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NCT00003389 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

355 / 414413 / 414Not reported / Not reported
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.

401 / 422422 / 422Not reported / Not reported

Group identifiers: EG000: Arm A (ABVD) · EG001: Arm B (Stanford V)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      422
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      422
    term
    Allergy-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      422
    term
    Middle ear/hearing
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      422
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      230
      num At Risk
      422
    term
    Leukocytes decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      175
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      328
      num At Risk
      422
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      313
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      293
      num At Risk
      422
    term
    Neutrophils decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      422
    term
    Platelets decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      422
    term
    Transfusion: pRBCs
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      422
    term
    Conduction abnormality
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      422
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      422
    term
    Supraventricular arrhythmias

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      422
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      374
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      412
      num At Risk
      422
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      378
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      394
      num At Risk
      422
    term
    Leukocytes decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      319
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      379
      num At Risk
      422
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      341
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      354
      num At Risk
      422
    term
    Neutrophils decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      422
    term
    Platelets decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      422
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      422
    term
    Phlebitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      320
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      311
      num At Risk
      422
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      422
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      422
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      422
    term
    Sweating
Complete source fields
event Groups
  1. description
    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
    EG000
    other Num Affected
    413
    other Num At Risk
    414
    serious Num Affected
    355
    serious Num At Risk
    414
    title
    Arm A (ABVD)
  2. description
    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
    EG001
    other Num Affected
    422
    other Num At Risk
    422
    serious Num Affected
    401
    serious Num At Risk
    422
    title
    Arm B (Stanford V)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      422
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      374
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      412
      num At Risk
      422
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      378
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      394
      num At Risk
      422
    term
    Leukocytes decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      319
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      379
      num At Risk
      422
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      341
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      354
      num At Risk
      422
    term
    Neutrophils decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      422
    term
    Platelets decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      422
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      422
    term
    Phlebitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      320
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      311
      num At Risk
      422
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      422
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      422
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      422
    term
    Sweating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      422
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      422
    term
    Allergy-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      422
    term
    Middle ear/hearing
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      422
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      230
      num At Risk
      422
    term
    Leukocytes decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      175
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      328
      num At Risk
      422
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      313
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      293
      num At Risk
      422
    term
    Neutrophils decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      422
    term
    Platelets decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      422
    term
    Transfusion: pRBCs
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      422
    term
    Conduction abnormality
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      422
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      414
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      422
    term
    Supraventricular arrhythmias
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

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