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NCT01492088 · ADVERSE EVENTS

Adverse events

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30

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 first dose through 30 days after the last dose of study medication (Up to 15 months)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Brentuximab Vedotin 1.4 mg/kg: Phase 1

Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.

0 / 33 / 31 / 3
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only

Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

7 / 1616 / 166 / 16
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only

Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

1 / 1717 / 172 / 17

Group identifiers: EG000: Brentuximab Vedotin 1.4 mg/kg: Phase 1 · EG001: Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only · EG002: Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only

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
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Hepatotoxicity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Anaphylactic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with brentuximab 1.8 mg/kg and was not related.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Myalgia

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      17
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrointestinal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Gastritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Toothache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrointestinal motility disorder
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Brentuximab Vedotin 1.4 mg/kg: Phase 1
  2. deaths Num Affected
    6
    deaths Num At Risk
    16
    description
    Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    7
    serious Num At Risk
    16
    title
    Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
  3. deaths Num Affected
    2
    deaths Num At Risk
    17
    description
    Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    1
    serious Num At Risk
    17
    title
    Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      17
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrointestinal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Gastritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Toothache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Gastrointestinal motility disorder
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Hepatotoxicity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Anaphylactic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with brentuximab 1.8 mg/kg and was not related.
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    term
    Myalgia
time Frame
From the first dose through 30 days after the last dose of study medication (Up to 15 months)

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

Preserved source evidence · Not medical advice