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NCT04304144 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis · Source last updated 2025-03-05

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
First dose of study drug until 140 days after last dose of study drug (Maximum exposure: 38.90 months for Part A and 32.50 months for Part B)
Other-event reporting threshold
5%

Safety Set included all participants who were treated with at least 1 dose of CAEL-101. AE data were collected for the participants in the DLT period (Part A) by dose separately. Additionally, the AE data for participants in the DLT period were also collected regardless of dose level received along with the AE data collected during the Part A Continued Treatment (Part A) period as an Overall arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DLT Period (Part A): CAEL-101 500 mg/m^2

Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).

0 / 44 / 40 / 4
DLT Period (Part A): CAEL-101 750 mg/m^2

Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).

0 / 33 / 30 / 3
DLT Period (Part A): CAEL-101 1000 mg/m^2

Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).

1 / 66 / 60 / 6
Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD

Participants received CAEL-101 during the DLT period weekly as an IV infusion the first 4 weeks, and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study, in combination with the SoC CyBorD (cyclophosphamide, bortezomib, dexamethasone) chemotherapy.

9 / 1313 / 131 / 13
Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab

Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab.

7 / 1211 / 122 / 12

Group identifiers: EG000: DLT Period (Part A): CAEL-101 500 mg/m^2 · EG001: DLT Period (Part A): CAEL-101 750 mg/m^2 · EG002: DLT Period (Part A): CAEL-101 1000 mg/m^2 · EG003: Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD · EG004: Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Splenic Haematoma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Splenic Infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Cardiac Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Cardiac Failure Acute
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Acute Left Ventricular Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Atrial Fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Nodal Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Ventricular Fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Catheter Site Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Non-cardiac Chest Pain

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Atrial Fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ear Haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Vision Blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Conjunctival Haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Vitreous Floaters
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      6
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      13
      num Events
      18
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      7
    term
    Nausea
Complete source fields
description
Safety Set included all participants who were treated with at least 1 dose of CAEL-101. AE data were collected for the participants in the DLT period (Part A) by dose separately. Additionally, the AE data for participants in the DLT period were also collected regardless of dose level received along with the AE data collected during the Part A Continued Treatment (Part A) period as an Overall arm.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    DLT Period (Part A): CAEL-101 500 mg/m^2
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    DLT Period (Part A): CAEL-101 750 mg/m^2
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    DLT Period (Part A): CAEL-101 1000 mg/m^2
  4. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Participants received CAEL-101 during the DLT period weekly as an IV infusion the first 4 weeks, and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study, in combination with the SoC CyBorD (cyclophosphamide, bortezomib, dexamethasone) chemotherapy.
    id
    EG003
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    9
    serious Num At Risk
    13
    title
    Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD
  5. deaths Num Affected
    2
    deaths Num At Risk
    12
    description
    Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab.
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    7
    serious Num At Risk
    12
    title
    Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Atrial Fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ear Haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Vision Blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Conjunctival Haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Vitreous Floaters
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      6
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      13
      num Events
      18
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      13
      num Events
      11
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      7
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Splenic Haematoma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Splenic Infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Cardiac Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Cardiac Failure Acute
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Acute Left Ventricular Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Atrial Fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Nodal Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Ventricular Fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
    term
    Catheter Site Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
    term
    Non-cardiac Chest Pain
time Frame
First dose of study drug until 140 days after last dose of study drug (Maximum exposure: 38.90 months for Part A and 32.50 months for Part B)

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Preserved source evidence · Not medical advice