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NCT03053440 · ADVERSE EVENTS

Adverse events

A Study Comparing BGB-3111 and Ibrutinib in Participants With 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 5 years and 5 months
Other-event reporting threshold
3%

The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Ibrutinib

Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

50 / 9896 / 9819 / 99
Arm B: Zanubrutinib

Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

59 / 10199 / 10114 / 102

Group identifiers: EG000: Arm A: Ibrutinib · EG001: Arm B: 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      2
    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
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      4
    term
    Febrile 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
      1
      num At Risk
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Haemolytic anaemia
  4. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Haemorrhagic disorder
  5. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Hyperviscosity syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      4
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Acute left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      3
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Aortic valve incompetence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Aortic valve stenosis

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
      22
      num At Risk
      98
      num Events
      48
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      101
      num Events
      57
    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
      5
      num At Risk
      98
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      3
    term
    Increased tendency to bruise
  3. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      98
      num Events
      51
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      101
      num Events
      87
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      98
      num Events
      47
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      101
      num Events
      61
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      98
      num Events
      24
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      101
      num Events
      8
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      98
      num Events
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      8
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      6
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      6
    term
    Tinnitus
Complete source fields
description
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
event Groups
  1. deaths Num Affected
    19
    deaths Num At Risk
    99
    description
    Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
    id
    EG000
    other Num Affected
    96
    other Num At Risk
    98
    serious Num Affected
    50
    serious Num At Risk
    98
    title
    Arm A: Ibrutinib
  2. deaths Num Affected
    14
    deaths Num At Risk
    102
    description
    Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
    id
    EG001
    other Num Affected
    99
    other Num At Risk
    101
    serious Num Affected
    59
    serious Num At Risk
    101
    title
    Arm B: 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
      22
      num At Risk
      98
      num Events
      48
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      101
      num Events
      57
    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
      5
      num At Risk
      98
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      3
    term
    Increased tendency to bruise
  3. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      98
      num Events
      51
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      101
      num Events
      87
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      98
      num Events
      47
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      101
      num Events
      61
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      98
      num Events
      24
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      101
      num Events
      8
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      98
      num Events
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      8
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      6
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      101
      num Events
      6
    term
    Tinnitus
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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      2
    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
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      4
    term
    Febrile 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
      1
      num At Risk
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Haemolytic anaemia
  4. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Haemorrhagic disorder
  5. 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
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Hyperviscosity syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      101
      num Events
      4
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Acute left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      101
      num Events
      3
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Aortic valve incompetence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Aortic valve stenosis
time Frame
up to approximately 5 years and 5 months

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