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NCT03332017 · ADVERSE EVENTS

Adverse events

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma · Source last updated 2026-02-18

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
All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
Other-event reporting threshold
3%

All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.

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

Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

22 / 7162 / 7133 / 72
Zanubrutinib Plus Obinutuzumab

Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

75 / 143130 / 14351 / 145
Crossover Treatment

Participants in teh obinutuzumab monotherapy arm who experienced progressive disease or their disease did not respond to therapy after 12 months (confirmed by the independent central review) crossed over to receive zanubrutinib 160 mg twice a day orally in addition to obinutuzumab 1000 mg intravenously every 8 weeks for a maximum of 30 months or until disease progression at the investigator's discretion.

20 / 3632 / 3616 / 36

Group identifiers: EG000: Obinutuzumab Monotherapy · EG001: Zanubrutinib Plus Obinutuzumab · EG002: Crossover Treatment

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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    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
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Necrotic 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
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Aortic valve 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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Atrial fibrillation
  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
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Abdominal pain upper

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
      6
      num At Risk
      71
      num Events
      10
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      143
      num Events
      57
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      36
      num Events
      3
    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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      71
      num Events
      22
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      143
      num Events
      61
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      36
      num Events
      20
    term
    Neutropenia
  4. 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
      71
      num Events
      19
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      143
      num Events
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      36
      num Events
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      143
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      143
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Anal incontinence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
      num Events
      6
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      143
      num Events
      28
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      36
      num Events
      5
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      71
      num Events
      17
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      143
      num Events
      44
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      36
      num Events
      6
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Gingival bleeding
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      71
      num Events
      14
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      143
      num Events
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Nausea
Complete source fields
description
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
event Groups
  1. deaths Num Affected
    33
    deaths Num At Risk
    72
    description
    Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    EG000
    other Num Affected
    62
    other Num At Risk
    71
    serious Num Affected
    22
    serious Num At Risk
    71
    title
    Obinutuzumab Monotherapy
  2. deaths Num Affected
    51
    deaths Num At Risk
    145
    description
    Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    EG001
    other Num Affected
    130
    other Num At Risk
    143
    serious Num Affected
    75
    serious Num At Risk
    143
    title
    Zanubrutinib Plus Obinutuzumab
  3. deaths Num Affected
    16
    deaths Num At Risk
    36
    description
    Participants in teh obinutuzumab monotherapy arm who experienced progressive disease or their disease did not respond to therapy after 12 months (confirmed by the independent central review) crossed over to receive zanubrutinib 160 mg twice a day orally in addition to obinutuzumab 1000 mg intravenously every 8 weeks for a maximum of 30 months or until disease progression at the investigator's discretion.
    id
    EG002
    other Num Affected
    32
    other Num At Risk
    36
    serious Num Affected
    20
    serious Num At Risk
    36
    title
    Crossover Treatment
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
      6
      num At Risk
      71
      num Events
      10
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      143
      num Events
      57
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      36
      num Events
      3
    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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      71
      num Events
      22
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      143
      num Events
      61
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      36
      num Events
      20
    term
    Neutropenia
  4. 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
      71
      num Events
      19
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      143
      num Events
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      36
      num Events
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      143
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      143
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Anal incontinence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
      num Events
      6
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      143
      num Events
      28
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      36
      num Events
      5
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      71
      num Events
      17
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      143
      num Events
      44
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      36
      num Events
      6
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      143
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Gingival bleeding
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      71
      num Events
      14
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      143
      num Events
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Nausea
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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    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
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Necrotic 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
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Aortic valve 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
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Atrial fibrillation
  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
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      71
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Abdominal pain upper
time Frame
All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.

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