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NCT03907488 · ADVERSE EVENTS

Adverse events

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma · Source last updated 2026-08-04

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
Up to 2 years
Other-event reporting threshold
5%

Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Chemotherapy, Nivolumab, Radiation)

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

140 / 481468 / 4817 / 487
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

18 / 476465 / 47614 / 483

Group identifiers: EG000: Arm I (Chemotherapy, Nivolumab, Radiation) · EG001: Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      476
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Blood and lymphatic system disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      476
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      476
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      476
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Cardiac disorders-Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Pericardial effusion

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      251
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      252
      num At Risk
      476
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      476
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      476
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      476
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      476
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      476
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      476
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      476
    term
    Bloating
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      240
      num At Risk
      476
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      173
      num At Risk
      476
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      476
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      476
    term
    Dyspepsia
Complete source fields
description
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    487
    description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
    id
    EG000
    other Num Affected
    468
    other Num At Risk
    481
    serious Num Affected
    140
    serious Num At Risk
    481
    title
    Arm I (Chemotherapy, Nivolumab, Radiation)
  2. deaths Num Affected
    14
    deaths Num At Risk
    483
    description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
    id
    EG001
    other Num Affected
    465
    other Num At Risk
    476
    serious Num Affected
    18
    serious Num At Risk
    476
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      251
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      252
      num At Risk
      476
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      476
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      476
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      476
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      476
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      476
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      476
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      476
    term
    Bloating
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      240
      num At Risk
      476
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      173
      num At Risk
      476
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      476
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      476
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      476
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Blood and lymphatic system disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      476
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      476
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      476
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Cardiac disorders-Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      481
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      476
    term
    Pericardial effusion
time Frame
Up to 2 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice