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NCT03947255 · ADVERSE EVENTS

Adverse events

A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma · Source last updated 2023-10-13

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
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
Other-event reporting threshold
5%

The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Classic Hodgkin Lymphoma

Participants with classic Hodgkin lymphoma

0 / 55 / 50 / 6
PTCL

Participants with peripheral T cell lymphoma

2 / 66 / 62 / 6

Group identifiers: EG000: Classic Hodgkin Lymphoma · EG001: PTCL

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
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastroenteritis norovirus
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ankle fracture

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
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gait disturbance
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Localised infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Oral infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Vaginal infection
Complete source fields
description
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants with classic Hodgkin lymphoma
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Classic Hodgkin Lymphoma
  2. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants with peripheral T cell lymphoma
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    PTCL
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gait disturbance
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Localised infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Oral infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Vaginal infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastroenteritis norovirus
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ankle fracture
time Frame
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months

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Preserved source evidence · Not medical advice