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NCT01109069 · ADVERSE EVENTS

Adverse events

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia · Source last updated 2020-05-27

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
8 Years, 5 months. This is a safety longterm follow-up study, it doesn't have any common milestones.
Other-event reporting threshold
4%

Adverse event data collection included Grade 3 or 4 AEs and major hemorrhage AEs, and the following: Grade 2 or higher eye-related AEs, and AEs of any grade that were serious, an +other malignancy, or led to dose reduction or treatment discontinuation.

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

This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

111 / 199114 / 199111 / 199

Group identifiers: EG000: IBRUTINIB/PCI-32765

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      199
      num Events
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      199
      num Events
      25
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Arteriosclerosis coronary artery
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Bundle branch block left
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Bundle branch block right
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Cardiac failure congestive

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      199
      num Events
      24
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      23
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      199
      num Events
      20
    term
    Cataract
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
      num Events
      10
    term
    Diarrohea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
      num Events
      10
    term
    Upper Respiratory Track Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      199
      num Events
      59
    term
    Lymphocyte count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      199
      num Events
      32
    term
    Neutrophil Count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      199
      num Events
      12
    term
    White Blood cell count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      15
    term
    Hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      199
      num Events
      197
    term
    Hypertension
Complete source fields
description
Adverse event data collection included Grade 3 or 4 AEs and major hemorrhage AEs, and the following: Grade 2 or higher eye-related AEs, and AEs of any grade that were serious, an +other malignancy, or led to dose reduction or treatment discontinuation.
event Groups
  1. deaths Num Affected
    111
    deaths Num At Risk
    199
    description
    This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
    id
    EG000
    other Num Affected
    114
    other Num At Risk
    199
    serious Num Affected
    111
    serious Num At Risk
    199
    title
    IBRUTINIB/PCI-32765
frequency Threshold
4
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      199
      num Events
      24
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      23
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      199
      num Events
      20
    term
    Cataract
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
      num Events
      10
    term
    Diarrohea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      199
      num Events
      10
    term
    Upper Respiratory Track Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      199
      num Events
      59
    term
    Lymphocyte count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      199
      num Events
      32
    term
    Neutrophil Count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      199
      num Events
      12
    term
    White Blood cell count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      15
    term
    Hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      199
      num Events
      197
    term
    Hypertension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      199
      num Events
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      199
      num Events
      25
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      199
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Arteriosclerosis coronary artery
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Bundle branch block left
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Bundle branch block right
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    term
    Cardiac failure congestive
time Frame
8 Years, 5 months. This is a safety longterm follow-up study, it doesn't have any common milestones.

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