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NCT01962792 · ADVERSE EVENTS

Adverse events

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2021-12-21

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
4 years, 2months
Other-event reporting threshold
0%

The Deaths reported are Death during treatment and within 30 Days of Last Study Treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 (560 mg)

Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib

2 / 33 / 30 / 3
Cohort 2a (560 mg)

Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib

5 / 55 / 54 / 5
Cohort 2b (560 mg)

Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone

17 / 1717 / 179 / 17
All RP2D (840 mg)

Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone

59 / 5958 / 5922 / 59

Group identifiers: EG000: Cohort 1 (560 mg) · EG001: Cohort 2a (560 mg) · EG002: Cohort 2b (560 mg) · EG003: All RP2D (840 mg)

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
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      59
      num Events
      6
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Atrial Flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Mitral valve disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Ventricular tachycardia

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      59
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      59
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      59
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      59
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      59
    term
    Hyperbilirubinaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      59
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      59
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      59
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      59
    term
    Acute kidney injury
Complete source fields
description
The Deaths reported are Death during treatment and within 30 Days of Last Study Treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Cohort 1 (560 mg)
  2. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Cohort 2a (560 mg)
  3. deaths Num Affected
    9
    deaths Num At Risk
    17
    description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    17
    serious Num At Risk
    17
    title
    Cohort 2b (560 mg)
  4. deaths Num Affected
    22
    deaths Num At Risk
    59
    description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    EG003
    other Num Affected
    58
    other Num At Risk
    59
    serious Num Affected
    59
    serious Num At Risk
    59
    title
    All RP2D (840 mg)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      59
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      59
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      59
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      59
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      59
    term
    Hyperbilirubinaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      59
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      59
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      59
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      59
    term
    Acute kidney injury
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      59
      num Events
      6
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Atrial Flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Mitral valve disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Ventricular tachycardia
time Frame
4 years, 2months

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Preserved source evidence · Not medical advice