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NCT04512235 · OUTCOME

Change From Baseline in the Short Form-36 (SF-36) Version 2 (v2) Physical Component Score (PCS)

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
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 50

What was measured

The SF-36v2 is a self-administered questionnaire containing 36 items that measure health on functional status, well-being, and overall evaluation of health in 8 domains, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, using scaled, ordinal responses (for example, All of the time, Most of the time, A good bit of the time). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, with higher scores indicating an increased quality of life. The 8 multi-item scales are aggregated and summed to give the final PCS. The final score ranges from 0-100, with higher scores indicating an increased quality of life.

Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported for Intent-to-Treat Set. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure.

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 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 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 Treatment115
Placebo + Plasma Cell Dyscrasia Treatment57

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment4.048.581Not reportedNot reportedNot reported
Placebo + Plasma Cell Dyscrasia Treatment3.358.485Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.581
        value
        4.04
      2. group Id
        OG001
        spread
        8.485
        value
        3.35
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    2. group Id
      OG001
      value
      57
    units
    Participants
description
The SF-36v2 is a self-administered questionnaire containing 36 items that measure health on functional status, well-being, and overall evaluation of health in 8 domains, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, using scaled, ordinal responses (for example, All of the time, Most of the time, A good bit of the time). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, with higher scores indicating an increased quality of life. The 8 multi-item scales are aggregated and summed to give the final PCS. The final score ranges from 0-100, with higher scores indicating an increased quality of life.
dispersion Type
Standard Deviation
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 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 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
MEAN
population Description
Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported for Intent-to-Treat Set. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, Week 50
title
Change From Baseline in the Short Form-36 (SF-36) Version 2 (v2) Physical Component Score (PCS)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice