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NCT00848926 · ADVERSE EVENTS

Adverse events

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma · Source last updated 2017-03-13

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
Treatment-emergent adverse events through 30 days after last dose (up to 12 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

25 / 10297 / 102Not reported / Not reported

Group identifiers: EG000: Brentuximab Vedotin

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
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Gastrointestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Haematemesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Candidiasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Cellulitis

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 (13.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      102
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      102
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      102
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      102
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      102
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      102
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      102
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      102
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      102
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      102
    term
    Pain
Complete source fields
event Groups
  1. description
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    EG000
    other Num Affected
    97
    other Num At Risk
    102
    serious Num Affected
    25
    serious Num At Risk
    102
    title
    Brentuximab Vedotin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      102
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      102
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      102
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      102
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      102
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      102
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      102
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      102
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      102
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      102
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      102
    term
    Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Gastrointestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Haematemesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Candidiasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
    term
    Cellulitis
time Frame
Treatment-emergent adverse events through 30 days after last dose (up to 12 months)

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