NCT04504825 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-47 months after the study randomization.)

What was measured

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, at any dose, that was not necessarily related to the treatment. A TEAE was an AE with an occurrence defined as follows: last study intervention day-first study intervention day + 140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Analysis population: Safety Set: all randomized participants who received at least 1 dose of the study intervention. As prespecified, data collected and reported as 'Overall (All Safety Set Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'.

Groups in this outcome

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	84
Placebo + Plasma Cell Dyscrasia Treatment	40

Reported measurements

Overall (All Safety Set Participants)

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	84
Placebo + Plasma Cell Dyscrasia Treatment	40

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	84	Not reported	Not reported	Not reported	Not reported
Placebo + Plasma Cell Dyscrasia Treatment	40	Not reported	Not reported	Not reported	Not reported

FLC Subtype Kappa

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	25
Placebo + Plasma Cell Dyscrasia Treatment	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	25	Not reported	Not reported	Not reported	Not reported
Placebo + Plasma Cell Dyscrasia Treatment	6	Not reported	Not reported	Not reported	Not reported

FLC Subtype Lambda

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	57
Placebo + Plasma Cell Dyscrasia Treatment	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	57	Not reported	Not reported	Not reported	Not reported
Placebo + Plasma Cell Dyscrasia Treatment	34	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
84
group Id
OG001
value
40
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
40
units
Participants
title
Overall (All Safety Set Participants)
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
6
units
Participants
title
FLC Subtype Kappa
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
34
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
34
units
Participants
title
FLC Subtype Lambda

denoms

counts
group Id
OG000
value
84
group Id
OG001
value
40
units
Participants

description

groups

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
OG000
title
CAEL-101 + Plasma Cell Dyscrasia Treatment
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
OG001
title
Placebo + Plasma Cell Dyscrasia Treatment

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Set: all randomized participants who received at least 1 dose of the study intervention. As prespecified, data collected and reported as 'Overall (All Safety Set Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'.

reporting Status

POSTED

time Frame

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

title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice