Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04512235 · OUTCOME

Frequency of CVHs

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.

Measure
NUMBER
Unit
CV-related hospitalizations/year
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-49 months after the study randomization.)

What was measured

CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of CVH was calculated using negative binomial regression analysis with study intervention, study, geographic region, daratumumab usage at Baseline, and offset term equal to log of each participant's follow-up time for cardiovascular hospitalization included in the model.

Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized 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

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment187
Placebo + Plasma Cell Dyscrasia Treatment94

Reported measurements

Overall (All Randomized Participants)

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment187
Placebo + Plasma Cell Dyscrasia Treatment94
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment0.36Not reported0.240.56Not reported
Placebo + Plasma Cell Dyscrasia Treatment0.48Not reported0.260.88Not reported
FLC Subtype Kappa

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment23
Placebo + Plasma Cell Dyscrasia Treatment18
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment0.31Not reported0.091.12Not reported
Placebo + Plasma Cell Dyscrasia Treatment0.60Not reported0.172.14Not reported
FLC Subtype Lambda

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment162
Placebo + Plasma Cell Dyscrasia Treatment75
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment0.35Not reported0.220.56Not reported
Placebo + Plasma Cell Dyscrasia Treatment0.41Not reported0.200.85Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.24
        upper Limit
        0.56
        value
        0.36
      2. group Id
        OG001
        lower Limit
        0.26
        upper Limit
        0.88
        value
        0.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    Overall (All Randomized Participants)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.09
        upper Limit
        1.12
        value
        0.31
      2. group Id
        OG001
        lower Limit
        0.17
        upper Limit
        2.14
        value
        0.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    FLC Subtype Kappa
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.22
        upper Limit
        0.56
        value
        0.35
      2. group Id
        OG001
        lower Limit
        0.20
        upper Limit
        0.85
        value
        0.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        162
      2. group Id
        OG001
        value
        75
      units
      Participants
    title
    FLC Subtype Lambda
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      94
    units
    Participants
description
CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of CVH was calculated using negative binomial regression analysis with study intervention, study, geographic region, daratumumab usage at Baseline, and offset term equal to log of each participant's follow-up time for cardiovascular hospitalization included in the model.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
NUMBER
population Description
Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized 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, analysis for the study was conducted 18-49 months after the study randomization.)
title
Frequency of CVHs
type
SECONDARY
unit Of Measure
CV-related hospitalizations/year

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice