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NCT02195869 · ADVERSE EVENTS

Adverse events

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease · Source last updated 2019-07-11

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 subsequent therapy for cGVHD, up to 36.7 months
Other-event reporting threshold
5%

Adverse events were not collected by phase because the phase 1 part of the study confirmed the first dose level (420mg was acceptable for cGVHD subjects and it was used as the recommended Phase 2 dose (RP2D). The Safety Population was the same as the All-treated Population (ie, all subject who received at least 1 dose of ibrutinib at the RP2D)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase1b/Phase 2

Subjects receive daily dose of 420 mg of Ibrutinib capsules

22 / 4241 / 427 / 42

Group identifiers: EG000: Phase1b/Phase 2

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      42
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Acute lymphocytic leukaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Atrial fibrilation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Brain abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Bronchopulmonary aspergillosis

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      42
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    term
    Cardiac Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    term
    Eye disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      42
    term
    Gastrointestinal disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      42
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    term
    Mouth Ulceration
Complete source fields
description
Adverse events were not collected by phase because the phase 1 part of the study confirmed the first dose level (420mg was acceptable for cGVHD subjects and it was used as the recommended Phase 2 dose (RP2D). The Safety Population was the same as the All-treated Population (ie, all subject who received at least 1 dose of ibrutinib at the RP2D)
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    42
    description
    Subjects receive daily dose of 420 mg of Ibrutinib capsules
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    42
    serious Num Affected
    22
    serious Num At Risk
    42
    title
    Phase1b/Phase 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      42
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    term
    Cardiac Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    term
    Eye disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      42
    term
    Gastrointestinal disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      42
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    term
    Mouth Ulceration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      42
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Acute lymphocytic leukaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Atrial fibrilation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Brain abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    term
    Bronchopulmonary aspergillosis
time Frame
From first dose of study drug to within 30 days of last dose or starting subsequent therapy for cGVHD, up to 36.7 months

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Preserved source evidence · Not medical advice