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NCT02264574 · ADVERSE EVENTS

Adverse events

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) · Source last updated 2020-09-21

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
From first dose of study drug up to 30 days after the last dose of study drug. Median treatment duration for the IBR+OB arm was 42.3 (IBR) and 4.6 (OB) months. Median treatment duration for the CLB+OB arm was 5.1 (CLB) and 4.6 (OB) months. Final analysis data (data cutoff date: 17 October 2019).
Other-event reporting threshold
5%

One participant in the CLB+OB arm was randomized but went off study without any treatment. This participant had received baseline assessments and was included in all efficacy analyses but was excluded from safety population, i.e. not at risk for adverse event assessment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IBR+OB

Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.

69 / 113112 / 11322 / 113
CLB+OB

Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.

41 / 115111 / 11521 / 115

Group identifiers: EG000: IBR+OB · EG001: CLB+OB

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 Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      115
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Cardiac arrest

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 Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      115
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Spontaneous haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      115
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      115
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      115
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      115
    term
    Lacrimation increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      115
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      115
    term
    Abdominal pain
Complete source fields
description
One participant in the CLB+OB arm was randomized but went off study without any treatment. This participant had received baseline assessments and was included in all efficacy analyses but was excluded from safety population, i.e. not at risk for adverse event assessment.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    113
    description
    Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
    id
    EG000
    other Num Affected
    112
    other Num At Risk
    113
    serious Num Affected
    69
    serious Num At Risk
    113
    title
    IBR+OB
  2. deaths Num Affected
    21
    deaths Num At Risk
    115
    description
    Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    111
    other Num At Risk
    115
    serious Num Affected
    41
    serious Num At Risk
    115
    title
    CLB+OB
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      115
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Spontaneous haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      115
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      115
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      115
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      115
    term
    Lacrimation increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      115
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      115
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      115
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      115
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Atrial tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      113
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      115
    term
    Cardiac arrest
time Frame
From first dose of study drug up to 30 days after the last dose of study drug. Median treatment duration for the IBR+OB arm was 42.3 (IBR) and 4.6 (OB) months. Median treatment duration for the CLB+OB arm was 5.1 (CLB) and 4.6 (OB) months. Final analysis data (data cutoff date: 17 October 2019).

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