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NCT04512235 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES) · Source last updated 2026-06-17

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 18-49 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.

132 / 187179 / 18744 / 187
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.

68 / 9491 / 9430 / 94

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
      1
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Leukocytosis
  3. 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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Myelosuppression
  4. 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
      187
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Splenic Embolism
  5. 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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      94
    term
    Cardiac Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    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
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      94
    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
      187
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Cardiac Arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Atrial Flutter
  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
      187
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    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
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Angina Pectoris

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
      44
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      94
    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
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      94
    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
      18
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      94
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Cardiac Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Vision Blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dry Eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      94
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      94
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      94
    term
    Nausea
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
    44
    deaths Num At Risk
    187
    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
    179
    other Num At Risk
    187
    serious Num Affected
    132
    serious Num At Risk
    187
    title
    CAEL-101 + Plasma Cell Dyscrasia Treatment
  2. deaths Num Affected
    30
    deaths Num At Risk
    94
    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
    91
    other Num At Risk
    94
    serious Num Affected
    68
    serious Num At Risk
    94
    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
      44
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      94
    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
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      94
    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
      18
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      94
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Cardiac Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Vision Blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dry Eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      94
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      94
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      94
    term
    Nausea
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
      1
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Leukocytosis
  3. 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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Myelosuppression
  4. 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
      187
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Splenic Embolism
  5. 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
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      94
    term
    Cardiac Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    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
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      94
    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
      187
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Cardiac Arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Atrial Flutter
  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
      187
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    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
      4
      num At Risk
      187
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Angina Pectoris
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 18-49 months after the study randomization.)

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