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NCT03336333 · ADVERSE EVENTS

Adverse events

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL · Source last updated 2026-03-09

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 and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021)
Other-event reporting threshold
3%

All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Bendamustine + Rituximab Without Del(17p)

Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)

113 / 227214 / 22714 / 238
Cohort 1: Zanubrutinib Without Del(17p)

Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression

88 / 240208 / 24016 / 241
Cohort 2: Zanubrutinib With Del(17p)

Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression

45 / 111104 / 1118 / 111

Group identifiers: EG000: Cohort 1: Bendamustine + Rituximab Without Del(17p) · EG001: Cohort 1: Zanubrutinib Without Del(17p) · EG002: Cohort 2: Zanubrutinib With Del(17p)

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
      5
      num At Risk
      227
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      111
      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
      11
      num At Risk
      227
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      111
      num Events
      1
    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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    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
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Pancytopenia
  6. 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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Angina pectoris
  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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      240
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Atrial fibrillation
  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
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Bradycardia

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
      41
      num At Risk
      227
      num Events
      65
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      111
      num Events
      7
    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
      7
      num At Risk
      227
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    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
      101
      num At Risk
      227
      num Events
      233
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      240
      num Events
      62
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      111
      num Events
      28
    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
      30
      num At Risk
      227
      num Events
      62
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      240
      num Events
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      111
      num Events
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      240
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      111
      num Events
      2
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      111
      num Events
      10
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      227
      num Events
      49
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      240
      num Events
      26
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      111
      num Events
      18
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      227
      num Events
      37
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      240
      num Events
      42
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      111
      num Events
      24
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      227
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      240
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      227
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      111
      num Events
      12
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      111
      num Events
      2
    term
    Haemorrhoids
Complete source fields
description
All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    238
    description
    Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    EG000
    other Num Affected
    214
    other Num At Risk
    227
    serious Num Affected
    113
    serious Num At Risk
    227
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. deaths Num Affected
    16
    deaths Num At Risk
    241
    description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    EG001
    other Num Affected
    208
    other Num At Risk
    240
    serious Num Affected
    88
    serious Num At Risk
    240
    title
    Cohort 1: Zanubrutinib Without Del(17p)
  3. deaths Num Affected
    8
    deaths Num At Risk
    111
    description
    Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    EG002
    other Num Affected
    104
    other Num At Risk
    111
    serious Num Affected
    45
    serious Num At Risk
    111
    title
    Cohort 2: Zanubrutinib With Del(17p)
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
      41
      num At Risk
      227
      num Events
      65
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      111
      num Events
      7
    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
      7
      num At Risk
      227
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    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
      101
      num At Risk
      227
      num Events
      233
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      240
      num Events
      62
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      111
      num Events
      28
    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
      30
      num At Risk
      227
      num Events
      62
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      240
      num Events
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      111
      num Events
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      240
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      111
      num Events
      2
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      240
      num Events
      16
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      111
      num Events
      10
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      227
      num Events
      49
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      240
      num Events
      26
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      111
      num Events
      18
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      227
      num Events
      37
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      240
      num Events
      42
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      111
      num Events
      24
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      227
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      240
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      227
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      240
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      111
      num Events
      12
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      111
      num Events
      2
    term
    Haemorrhoids
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
      5
      num At Risk
      227
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      111
      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
      11
      num At Risk
      227
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      111
      num Events
      1
    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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    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
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Pancytopenia
  6. 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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      240
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Angina pectoris
  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
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      240
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      240
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Atrial fibrillation
  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
      227
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      240
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Bradycardia
time Frame
All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021)

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Preserved source evidence · Not medical advice