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NCT03462719 · ADVERSE EVENTS

Adverse events

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-08-31

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 4 years 10 months
Other-event reporting threshold
5%

The safety analysis set is defined as all randomized participants who received at least one dose of any one of the four study drugs (ibrutinib, venetoclax, chlorambucil, or obinutuzumab).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Arm A (Ibrutinib + Venetoclax)

Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.

49 / 10698 / 10617 / 106
Treatment Arm B (Chlorambucil + Obinutuzumab)

Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.

30 / 10598 / 10536 / 105

Group identifiers: EG000: Treatment Arm A (Ibrutinib + Venetoclax) · EG001: Treatment Arm B (Chlorambucil + Obinutuzumab)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Acute Myocardial Infarction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Angina Unstable
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Cardiac Arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Cardiac Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Cardiac Failure Congestive
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Myocardial Infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Sinus Node Dysfunction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Supraventricular Tachycardia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      105
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      105
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      105
    term
    Atrial Fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Vertigo
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      105
    term
    Abdominal Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      105
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Mouth Ulceration
Complete source fields
description
The safety analysis set is defined as all randomized participants who received at least one dose of any one of the four study drugs (ibrutinib, venetoclax, chlorambucil, or obinutuzumab).
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    106
    description
    Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    98
    other Num At Risk
    106
    serious Num Affected
    49
    serious Num At Risk
    106
    title
    Treatment Arm A (Ibrutinib + Venetoclax)
  2. deaths Num Affected
    36
    deaths Num At Risk
    105
    description
    Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    98
    other Num At Risk
    105
    serious Num Affected
    30
    serious Num At Risk
    105
    title
    Treatment Arm B (Chlorambucil + Obinutuzumab)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      105
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      105
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      105
    term
    Atrial Fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Vertigo
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      105
    term
    Abdominal Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      105
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Mouth Ulceration
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      105
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      105
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Acute Myocardial Infarction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Angina Unstable
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Cardiac Arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Cardiac Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Cardiac Failure Congestive
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Myocardial Infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    term
    Sinus Node Dysfunction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      106
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      105
    term
    Supraventricular Tachycardia
time Frame
Up to 4 years 10 months

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