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NCT00742560 · ADVERSE EVENTS

Adverse events

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma · Source last updated 2018-01-10

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
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months).
Other-event reporting threshold
5%

TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

0 / 33 / 3Not reported / Not reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

3 / 33 / 3Not reported / Not reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

12 / 2222 / 22Not reported / Not reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

21 / 3636 / 36Not reported / Not reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

21 / 3737 / 37Not reported / Not reported

Group identifiers: EG000: Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) · EG001: Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) · EG002: Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) · EG003: Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) · EG004: Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      37
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    LYMPHOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    PANCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    ANGINA PECTORIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    ATRIAL FIBRILLATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    BRADYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    DIVERTICULAR PERFORATION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    GASTROINTESTINAL HAEMORRHAGE

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
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      37
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    HAEMOGLOBINAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    INCREASED TENDENCY TO BRUISE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    IRON DEFICIENCY ANAEMIA
  6. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      37
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      37
    term
    LYMPHADENOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      37
    term
    LYMPHOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      37
    term
    NEUTROPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    PANCYTOPENIA
  11. 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
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      37
    term
    THROMBOCYTOPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    ATRIAL FIBRILLATION
Complete source fields
description
TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
event Groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    EG002
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    12
    serious Num At Risk
    22
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    EG003
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    21
    serious Num At Risk
    36
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  5. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    EG004
    other Num Affected
    37
    other Num At Risk
    37
    serious Num Affected
    21
    serious Num At Risk
    37
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (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
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      37
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    HAEMOGLOBINAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    INCREASED TENDENCY TO BRUISE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    IRON DEFICIENCY ANAEMIA
  6. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      37
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      37
    term
    LYMPHADENOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      37
    term
    LYMPHOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      37
    term
    NEUTROPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    PANCYTOPENIA
  11. 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
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      37
    term
    THROMBOCYTOPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
    term
    ATRIAL FIBRILLATION
serious 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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      37
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    LYMPHOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    PANCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    ANGINA PECTORIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      37
    term
    ATRIAL FIBRILLATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    BRADYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    DIVERTICULAR PERFORATION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      36
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
    term
    GASTROINTESTINAL HAEMORRHAGE
time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months).

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Preserved source evidence · Not medical advice