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NCT03846427 · ADVERSE EVENTS

Adverse events

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma · Source last updated 2024-10-26

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 first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Other-event reporting threshold
3%

Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Zanubrutinib

Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

30 / 6861 / 6813 / 68

Group identifiers: EG000: Zanubrutinib

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Angina pectoris
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Coronary artery stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Faecaloma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    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 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Abdominal discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      68
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Toothache
Complete source fields
description
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    68
    description
    Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    68
    serious Num Affected
    30
    serious Num At Risk
    68
    title
    Zanubrutinib
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Abdominal discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      68
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Toothache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Angina pectoris
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Coronary artery stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Faecaloma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Gastrointestinal haemorrhage
time Frame
From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)

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Preserved source evidence · Not medical advice