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NCT00866047 · ADVERSE EVENTS

Adverse events

A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma · Source last updated 2017-03-22

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
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 / 5858 / 58Not 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
      58
    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
      1
      num At Risk
      58
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    term
    Arrhythmia supraventricular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Retinal vein occlusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Gastrointestinal haemorrhage

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
      5
      num At Risk
      58
    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
      6
      num At Risk
      58
    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
      11
      num At Risk
      58
    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
      8
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      58
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      58
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      58
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      58
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Oral pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      58
    term
    Vomiting
Complete source fields
event Groups
  1. description
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    EG000
    other Num Affected
    58
    other Num At Risk
    58
    serious Num Affected
    25
    serious Num At Risk
    58
    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
      5
      num At Risk
      58
    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
      6
      num At Risk
      58
    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
      11
      num At Risk
      58
    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
      8
      num At Risk
      58
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      58
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      58
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      58
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      58
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    term
    Oral pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      58
    term
    Vomiting
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
      58
    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
      1
      num At Risk
      58
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    term
    Arrhythmia supraventricular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Retinal vein occlusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    term
    Gastrointestinal haemorrhage
time Frame
Adverse events through 30 days after last dose (up to 12 months)

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

Preserved source evidence · Independent clinical review pending · Not medical advice