Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) 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
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures such as functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Subscale scores are transformed to 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Baseline is defined as the last non-missing measurement prior to JCARH125 infusion.
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
Group
Source count
Phase 2 600 x 10^6 Cells
4
Reported measurements
Global Health Status/QoL Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
-2.08
10.49
Not reported
Not reported
Not reported
Physical Functioning Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
-6.67
9.43
Not reported
Not reported
Not reported
Role Functioning Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
0.00
13.61
Not reported
Not reported
Not reported
Emotional Functioning Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
-6.25
7.98
Not reported
Not reported
Not reported
Cognitive Functioning Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
4.17
8.33
Not reported
Not reported
Not reported
Social Functioning Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
16.67
13.61
Not reported
Not reported
Not reported
Fatigue Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
5.56
6.42
Not reported
Not reported
Not reported
Pain Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
-4.17
8.33
Not reported
Not reported
Not reported
Nausea and Vomiting Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
4.17
8.33
Not reported
Not reported
Not reported
Dyspnea Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
-8.33
16.67
Not reported
Not reported
Not reported
Insomnia Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
0.00
27.22
Not reported
Not reported
Not reported
Appetite Loss Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
8.33
16.67
Not reported
Not reported
Not reported
Constipation Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
8.33
16.67
Not reported
Not reported
Not reported
Diarrhea Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
8.33
16.67
Not reported
Not reported
Not reported
Financial Difficulties Month 24
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 600 x 10^6 Cells
8.33
16.67
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
10.49
value
-2.08
title
Global Health Status/QoL Month 24
categories
measurements
group Id
OG000
spread
9.43
value
-6.67
title
Physical Functioning Month 24
categories
measurements
group Id
OG000
spread
13.61
value
0.00
title
Role Functioning Month 24
categories
measurements
group Id
OG000
spread
7.98
value
-6.25
title
Emotional Functioning Month 24
categories
measurements
group Id
OG000
spread
8.33
value
4.17
title
Cognitive Functioning Month 24
categories
measurements
group Id
OG000
spread
13.61
value
16.67
title
Social Functioning Month 24
categories
measurements
group Id
OG000
spread
6.42
value
5.56
title
Fatigue Month 24
categories
measurements
group Id
OG000
spread
8.33
value
-4.17
title
Pain Month 24
categories
measurements
group Id
OG000
spread
8.33
value
4.17
title
Nausea and Vomiting Month 24
categories
measurements
group Id
OG000
spread
16.67
value
-8.33
title
Dyspnea Month 24
categories
measurements
group Id
OG000
spread
27.22
value
0.00
title
Insomnia Month 24
categories
measurements
group Id
OG000
spread
16.67
value
8.33
title
Appetite Loss Month 24
denoms
counts
group Id
OG000
value
4
units
Participants
description
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures such as functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Subscale scores are transformed to 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Baseline is defined as the last non-missing measurement prior to JCARH125 infusion.
dispersion Type
Standard Deviation
groups
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 in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) in Phase 2
Triangle