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NCT02166463 · ADVERSE EVENTS

Adverse events

Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma · Source last updated 2026-07-29

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
From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Other-event reporting threshold
0%

Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (ABVE-PC)

Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.

11 / 287206 / 2874 / 289
ARM II (Bv-AVEPC)

Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.

66 / 295209 / 2952 / 298

Group identifiers: EG000: Arm I (ABVE-PC) · EG001: ARM II (Bv-AVEPC)

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
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      287
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      295
      num Events
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      295
      num Events
      6
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Esophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Gastrointestinal pain

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
      89
      num At Risk
      287
      num Events
      89
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      295
      num Events
      107
    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
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      287
      num Events
      90
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      295
      num Events
      83
    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
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      287
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      287
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Anal fistula
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      287
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      295
      num Events
      5
    term
    Constipation
Complete source fields
description
Adverse Events are collected using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). Per the protocol, SAE reporting requirements and expedited reporting of AEs did differ for the Bv-AVEPC arm, given that Bv was under IND. All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    289
    description
    Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    206
    other Num At Risk
    287
    serious Num Affected
    11
    serious Num At Risk
    287
    title
    Arm I (ABVE-PC)
  2. deaths Num Affected
    2
    deaths Num At Risk
    298
    description
    Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    209
    other Num At Risk
    295
    serious Num Affected
    66
    serious Num At Risk
    295
    title
    ARM II (Bv-AVEPC)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      287
      num Events
      89
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      295
      num Events
      107
    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
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      287
      num Events
      90
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      295
      num Events
      83
    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
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      287
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      287
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      295
      num Events
      0
    term
    Anal fistula
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      287
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      295
      num Events
      5
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      287
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      295
      num Events
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      295
      num Events
      6
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Esophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Gastrointestinal pain
time Frame
From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.

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