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NCT04266301 · OUTCOME

Change From Baseline in the European Quality of Life (EuroQol) - 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) Score Over Time

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Scores on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, every 3 cycles up to C48D1 (1 cycle = 28 days)

What was measured

The EQ-5D-5L comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. For each of the 5 dimensions, subject's responses are scored on a 5-point scale (1=no problem to 5=extreme problems). Change from baseline is being presented for EQ Index score. Index score is defined as a weighted combination of the levels of the 5-dimention scales, ranging from 0 to 1 (perfect health), with higher scores indicating better health-related quality of life. The United States value set from Pickard et al 2019 was used.

Analysis population: FAS population with non-missing baseline EQ-5D-5L assessments. For each post-baseline timepoint, FAS population with non-missing baseline and post-baseline EQ-5D-5L assessment. FAS comprised of all patients to whom study treatment had been assigned by randomization.

Groups in this outcome

Sabatolimab (MBG453) + Azacitidine

Participants were randomized to sabatolimab plus Azacitidine

Placebo + Azacitidine

Participants were randomized to placebo plus Azacitidine

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
Sabatolimab (MBG453) + Azacitidine	238
Placebo + Azacitidine	245

Reported measurements

Baseline (BL)

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	238
Placebo + Azacitidine	245

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.78	0.204	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.78	0.239	Not reported	Not reported	Not reported

Change from BL at Cycle (C) 3 Day (D) 1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	205
Placebo + Azacitidine	199

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.00	0.215	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.03	0.222	Not reported	Not reported	Not reported

Change from BL at C6D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	163
Placebo + Azacitidine	157

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.02	0.260	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.02	0.305	Not reported	Not reported	Not reported

Change from BL at C9D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	129
Placebo + Azacitidine	117

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.03	0.232	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.01	0.226	Not reported	Not reported	Not reported

Change from BL at C12D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	93
Placebo + Azacitidine	88

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.02	0.163	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.05	0.261	Not reported	Not reported	Not reported

Change from BL at C15D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	84
Placebo + Azacitidine	61

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.02	0.238	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.01	0.221	Not reported	Not reported	Not reported

Change from BL at C18D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	65
Placebo + Azacitidine	53

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.02	0.208	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.00	0.226	Not reported	Not reported	Not reported

Change from BL at C21D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	47
Placebo + Azacitidine	45

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.00	0.208	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.00	0.256	Not reported	Not reported	Not reported

Change from BL at C24D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	45
Placebo + Azacitidine	41

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	0.00	0.157	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.02	0.225	Not reported	Not reported	Not reported

Change from BL at C27D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	34
Placebo + Azacitidine	35

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.09	0.283	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.00	0.213	Not reported	Not reported	Not reported

Change from BL at C30D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	30
Placebo + Azacitidine	25

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.03	0.315	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.02	0.256	Not reported	Not reported	Not reported

Change from BL at C33D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	22
Placebo + Azacitidine	22

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.01	0.211	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.02	0.218	Not reported	Not reported	Not reported

Change from BL at C36D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	18
Placebo + Azacitidine	15

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.07	0.333	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.07	0.395	Not reported	Not reported	Not reported

Change from BL at C39D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	14
Placebo + Azacitidine	10

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.16	0.360	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.02	0.143	Not reported	Not reported	Not reported

Change from BL at C42D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	9
Placebo + Azacitidine	4

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.09	0.262	Not reported	Not reported	Not reported
Placebo + Azacitidine	-0.13	0.309	Not reported	Not reported	Not reported

Change from BL at C45D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	6
Placebo + Azacitidine	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.12	0.262	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.17	0.069	Not reported	Not reported	Not reported

Change from BL at C48D1

Analysis denominator · Participants

Group	Source count
Sabatolimab (MBG453) + Azacitidine	1
Placebo + Azacitidine	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sabatolimab (MBG453) + Azacitidine	-0.07	0.000	Not reported	Not reported	Not reported
Placebo + Azacitidine	0.06	0.087	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.204
value
0.78
group Id
OG001
spread
0.239
value
0.78
denoms
counts
group Id
OG000
value
238
group Id
OG001
value
245
units
Participants
title
Baseline (BL)
categories
measurements
group Id
OG000
spread
0.215
value
0.00
group Id
OG001
spread
0.222
value
-0.03
denoms
counts
group Id
OG000
value
205
group Id
OG001
value
199
units
Participants
title
Change from BL at Cycle (C) 3 Day (D) 1
categories
measurements
group Id
OG000
spread
0.260
value
-0.02
group Id
OG001
spread
0.305
value
-0.02
denoms
counts
group Id
OG000
value
163
group Id
OG001
value
157
units
Participants
title
Change from BL at C6D1
categories
measurements
group Id
OG000
spread
0.232
value
0.03
group Id
OG001
spread
0.226
value
-0.01
denoms
counts
group Id
OG000
value
129
group Id
OG001
value
117
units
Participants
title
Change from BL at C9D1
categories
measurements
group Id
OG000
spread
0.163
value
0.02
group Id
OG001
spread
0.261
value
-0.05
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
88
units
Participants
title
Change from BL at C12D1
categories
measurements
group Id
OG000
spread
0.238
value
-0.02
group Id
OG001
spread
0.221
value
0.01
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
61
units
Participants
title
Change from BL at C15D1
categories
measurements
group Id
OG000
spread
0.208
value
-0.02
group Id
OG001
spread
0.226
value
0.00
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
53
units
Participants
title
Change from BL at C18D1
categories
measurements
group Id
OG000
spread
0.208
value
0.00
group Id
OG001
spread
0.256
value
0.00
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
45
units
Participants
title
Change from BL at C21D1
categories
measurements
group Id
OG000
spread
0.157
value
0.00
group Id
OG001
spread
0.225
value
0.02
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
41
units
Participants
title
Change from BL at C24D1
categories
measurements
group Id
OG000
spread
0.283
value
-0.09
group Id
OG001
spread
0.213
value
0.00
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
35
units
Participants
title
Change from BL at C27D1
categories
measurements
group Id
OG000
spread
0.315
value
-0.03
group Id
OG001
spread
0.256
value
0.02
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
25
units
Participants
title
Change from BL at C30D1
categories
measurements
group Id
OG000
spread
0.211
value
-0.01
group Id
OG001
spread
0.218
value
-0.02
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
22
units
Participants
title
Change from BL at C33D1

denoms

counts
group Id
OG000
value
238
group Id
OG001
value
245
units
Participants

description

The EQ-5D-5L comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. For each of the 5 dimensions, subject's responses are scored on a 5-point scale (1=no problem to 5=extreme problems). Change from baseline is being presented for EQ Index score. Index score is defined as a weighted combination of the levels of the 5-dimention scales, ranging from 0 to 1 (perfect health), with higher scores indicating better health-related quality of life. The United States value set from Pickard et al 2019 was used.

dispersion Type

Standard Deviation

groups

description
Participants were randomized to sabatolimab plus Azacitidine
id
OG000
title
Sabatolimab (MBG453) + Azacitidine
description
Participants were randomized to placebo plus Azacitidine
id
OG001
title
Placebo + Azacitidine

param Type

MEAN

population Description

FAS population with non-missing baseline EQ-5D-5L assessments. For each post-baseline timepoint, FAS population with non-missing baseline and post-baseline EQ-5D-5L assessment. FAS comprised of all patients to whom study treatment had been assigned by randomization.

reporting Status

POSTED

time Frame

Baseline, every 3 cycles up to C48D1 (1 cycle = 28 days)

title

Change From Baseline in the European Quality of Life (EuroQol) - 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) Score Over Time

type

SECONDARY

unit Of Measure

Scores on a scale

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

Preserved source evidence · Not medical advice