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NCT03332173 · ADVERSE EVENTS

Adverse events

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM) · 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
Up to approximately 3 years and 5 months
Other-event reporting threshold
3%

A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).

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

Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity

25 / 4444 / 447 / 44

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Arteriosclerosis coronary artery
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Coronary artery disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Macular degeneration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Dysbiosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Upper gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Abscess limb
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Acute hepatitis B
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Epididymitis

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Conjunctival haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Ocular discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Retinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Flatulence
Complete source fields
description
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    44
    description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    id
    EG000
    other Num Affected
    44
    other Num At Risk
    44
    serious Num Affected
    25
    serious Num At Risk
    44
    title
    Zanubrutinib
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Conjunctival haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Ocular discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Retinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    term
    Flatulence
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Arteriosclerosis coronary artery
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Coronary artery disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Macular degeneration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Dysbiosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Upper gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Abscess limb
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Acute hepatitis B
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Epididymitis
time Frame
Up to approximately 3 years and 5 months

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