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NCT04504825 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) · Source last updated 2026-07-02

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
Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, safety analysis for the study was conducted 18-47 months after the study randomization.)
Other-event reporting threshold
5%

Serious and non-serious adverse events based upon the Safety Set: all randomized participants who received at least 1 dose of study intervention. All-cause mortality based upon the Intent-to-treat Set: all participants who were randomized. All deaths, regardless of causality or whether they were reported as a reason for study discontinuation, are reported in the All-Cause Mortality section. Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CAEL-101 + Plasma Cell Dyscrasia Treatment

During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.

73 / 8477 / 8446 / 84
Placebo + Plasma Cell Dyscrasia Treatment

During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.

33 / 4037 / 4022 / 41

Group identifiers: EG000: CAEL-101 + Plasma Cell Dyscrasia Treatment · EG001: Placebo + Plasma Cell Dyscrasia Treatment

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Splenic Haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      40
    term
    Cardiac Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Cardiac Arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiac Failure Congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Atrial Fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Cardiogenic Shock
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiac Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiorenal Syndrome

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Iron Deficiency Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Cardiac Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      40
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      40
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Abdominal Distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Abdominal Pain
Complete source fields
description
Serious and non-serious adverse events based upon the Safety Set: all randomized participants who received at least 1 dose of study intervention. All-cause mortality based upon the Intent-to-treat Set: all participants who were randomized. All deaths, regardless of causality or whether they were reported as a reason for study discontinuation, are reported in the All-Cause Mortality section. Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section.
event Groups
  1. deaths Num Affected
    46
    deaths Num At Risk
    84
    description
    During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    EG000
    other Num Affected
    77
    other Num At Risk
    84
    serious Num Affected
    73
    serious Num At Risk
    84
    title
    CAEL-101 + Plasma Cell Dyscrasia Treatment
  2. deaths Num Affected
    22
    deaths Num At Risk
    41
    description
    During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    40
    serious Num Affected
    33
    serious Num At Risk
    40
    title
    Placebo + Plasma Cell Dyscrasia Treatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Iron Deficiency Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Cardiac Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      40
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      40
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Abdominal Distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Abdominal Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Splenic Haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      40
    term
    Cardiac Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Cardiac Arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiac Failure Congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Atrial Fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Cardiogenic Shock
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiac Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Cardiorenal Syndrome
time Frame
Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, safety analysis for the study was conducted 18-47 months after the study randomization.)

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