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NCT01722487 · ADVERSE EVENTS

Adverse events

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL · Source last updated 2017-11-30

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 to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
Other-event reporting threshold
5%

269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PCI-32765

Ibrutinib 420 mg daily.

55 / 135133 / 135Not reported / Not reported
Chlorambucil

Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles

33 / 132123 / 132Not reported / Not reported

Group identifiers: EG000: PCI-32765 · EG001: Chlorambucil

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 (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Autoimmune haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Aortic valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Coronary artery disease

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 (17.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      132
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      132
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
    term
    Increased tendency to bruise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      132
    term
    Visual acuity reduced
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
    term
    Vitreous floaters
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Cataract
Complete source fields
description
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
event Groups
  1. description
    Ibrutinib 420 mg daily.
    id
    EG000
    other Num Affected
    133
    other Num At Risk
    135
    serious Num Affected
    55
    serious Num At Risk
    135
    title
    PCI-32765
  2. description
    Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
    id
    EG001
    other Num Affected
    123
    other Num At Risk
    132
    serious Num Affected
    33
    serious Num At Risk
    132
    title
    Chlorambucil
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      132
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      132
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
    term
    Increased tendency to bruise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      132
    term
    Visual acuity reduced
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
    term
    Vitreous floaters
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Cataract
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Autoimmune haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Aortic valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      135
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    term
    Coronary artery disease
time Frame
From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).

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