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NCT03430011 · OUTCOME

Change From Baseline (EQ-5D-5L) Index Score in Phase 2

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

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 and visit 24 month

What was measured

EQ-5D-5L is a standardized measure of health status that consists of descriptive system and Visual Analogue scale VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the dimensions are combined in a 5-digit number corresponding to response categories for successive dimensions using a scoring algorithm. The VAS system has endpoints labeled "the best health you can imagine" and "the worst health you can imagine." The scale is numbered from 0 to 100 with 0 corresponding to the worst imaginable health state and 100 corresponding to the best imaginable health state. A high score represents a better level of quality of life

Analysis population: All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol

Groups in this outcome

Phase 2 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion

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

Analysis denominator · Participants

GroupSource count
Phase 2 600 x 10^6 Cells4

Reported measurements

Mobility Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells-0.30.5Not reportedNot reportedNot reported
Self Care Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells0.00.0Not reportedNot reportedNot reported
Activity Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells0.30.5Not reportedNot reportedNot reported
Pain Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells0.00.0Not reportedNot reportedNot reported
Anxiety Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells0.31.0Not reportedNot reportedNot reported
Utility Index US Index Score
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells-0.00350.1193Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        -0.3
    title
    Mobility Index Score
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        0.0
    title
    Self Care Index Score
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        0.3
    title
    Activity Index Score
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        0.0
    title
    Pain Index Score
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        0.3
    title
    Anxiety Index Score
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1193
        value
        -0.0035
    title
    Utility Index US Index Score
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
EQ-5D-5L is a standardized measure of health status that consists of descriptive system and Visual Analogue scale VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the dimensions are combined in a 5-digit number corresponding to response categories for successive dimensions using a scoring algorithm. The VAS system has endpoints labeled "the best health you can imagine" and "the worst health you can imagine." The scale is numbered from 0 to 100 with 0 corresponding to the worst imaginable health state and 100 corresponding to the best imaginable health state. A high score represents a better level of quality of life
dispersion Type
Standard Deviation
groups
  1. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    OG000
    title
    Phase 2 600 x 10^6 Cells
param Type
MEAN
population Description
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
reporting Status
POSTED
time Frame
Baseline and visit 24 month
title
Change From Baseline (EQ-5D-5L) Index Score in Phase 2
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice