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NCT01105247 · ADVERSE EVENTS

Adverse events

Safety of PCI-32765 in Chronic Lymphocytic Leukemia · Source last updated 2014-03-31

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PCI-32765

PCI-32765: 420 mg daily or 840 mg daily

61 / 116116 / 116Not reported / Not reported
Food Effect

PCI-32765: 420 mg daily

7 / 1616 / 16Not reported / Not reported

Group identifiers: EG000: PCI-32765 · EG001: Food Effect

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Febrile neutropenia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Splenomegaly
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Idiopathic thrombocytopenic purpura
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Lymphocytosis
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Atrial fibrillation
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Angina pectoris
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Supraventricular tachycardia
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Vision blurred
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Abdominal pain
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Diarrhoea
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Abdominal adhesions
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Enterocolitis haemorrhagic

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Anaemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    term
    Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Thrombocytopenia
  4. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dry eye
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Cataract
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Conjunctivitis
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Constipation
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dyspepsia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Stomatitis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Gastrooesophageal reflux disease
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dry mouth
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Aphthous stomatitis
Complete source fields
event Groups
  1. description
    PCI-32765: 420 mg daily or 840 mg daily
    id
    EG000
    other Num Affected
    116
    other Num At Risk
    116
    serious Num Affected
    61
    serious Num At Risk
    116
    title
    PCI-32765
  2. description
    PCI-32765: 420 mg daily
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    7
    serious Num At Risk
    16
    title
    Food Effect
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Anaemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    term
    Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Thrombocytopenia
  4. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dry eye
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Cataract
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Conjunctivitis
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Constipation
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dyspepsia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Stomatitis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Gastrooesophageal reflux disease
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dry mouth
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Aphthous stomatitis
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Febrile neutropenia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Splenomegaly
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Idiopathic thrombocytopenic purpura
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Lymphocytosis
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Atrial fibrillation
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Angina pectoris
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Supraventricular tachycardia
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Vision blurred
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Abdominal pain
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Diarrhoea
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Abdominal adhesions
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      116
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Enterocolitis haemorrhagic

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