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NCT02631070 · OUTCOME

Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Score

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes · Source last updated 2021-12-17

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 and Cycle 3, Day 1 (C3 D1), C5 D1, C7 D1, Week 25, every other cycle during extension phase (C1 D1, C3 D1, C5 D1, etc. up to C59 D1) and end of treatment. Each cycle is composed of 21 days.

What was measured

The EORTC questionnaire is a validated health-related quality of life (HRQoL) measure applicable to participants with any cancer diagnosis. Version 3.0 of the questionnaire was used in the study. It is composed of 30 items that address 15 domains, including one global health status, functional domains, and symptom domains. Domain scores are transformed to a 0 to 100 scale, where higher scores on the global quality of life score indicate better function. As such, a positive change from Baseline score indicates an improvement in quality of life.

Analysis population: All treated participants who completed the EORTC QLQ-C30 assessment at baseline and at least one post-baseline assessment visit.

Groups in this outcome

Luspatercept

Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle

Placebo

Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle

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
Luspatercept	149
Placebo	76

Reported measurements

Cycle 3 Day 1 (C3 D1)

Analysis denominator · Participants

Group	Source count
Luspatercept	133
Placebo	69

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-4.1	21.01	Not reported	Not reported	Not reported
Placebo	0.1	15.95	Not reported	Not reported	Not reported

C5 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	129
Placebo	65

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.4	20.73	Not reported	Not reported	Not reported
Placebo	2.2	17.13	Not reported	Not reported	Not reported

C7 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	108
Placebo	59

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.1	23.04	Not reported	Not reported	Not reported
Placebo	-0.6	18.63	Not reported	Not reported	Not reported

Week 25

Analysis denominator · Participants

Group	Source count
Luspatercept	110
Placebo	53

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-1.8	21.75	Not reported	Not reported	Not reported
Placebo	0.2	18.88	Not reported	Not reported	Not reported

Extension Phase C1 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	48
Placebo	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	0.0	25.32	Not reported	Not reported	Not reported
Placebo	6.3	14.60	Not reported	Not reported	Not reported

Extension Phase C3 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	83
Placebo	17

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	2.0	19.68	Not reported	Not reported	Not reported
Placebo	-3.9	26.86	Not reported	Not reported	Not reported

Extension Phase C5 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	77
Placebo	15

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	0.8	18.40	Not reported	Not reported	Not reported
Placebo	0.6	20.04	Not reported	Not reported	Not reported

Extension Phase C7 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	74
Placebo	13

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-0.5	20.03	Not reported	Not reported	Not reported
Placebo	3.8	20.87	Not reported	Not reported	Not reported

Extension Phase C9 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	69
Placebo	7

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.4	18.42	Not reported	Not reported	Not reported
Placebo	11.9	19.75	Not reported	Not reported	Not reported

Extension Phase C11 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	60
Placebo	7

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-1.8	19.53	Not reported	Not reported	Not reported
Placebo	4.8	24.47	Not reported	Not reported	Not reported

Extension Phase C13 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	58
Placebo	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.6	20.84	Not reported	Not reported	Not reported
Placebo	8.3	24.15	Not reported	Not reported	Not reported

Extension Phase C15 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	57
Placebo	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	3.1	18.27	Not reported	Not reported	Not reported
Placebo	4.2	27.26	Not reported	Not reported	Not reported

Extension Phase C17 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	55
Placebo	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-0.6	19.03	Not reported	Not reported	Not reported
Placebo	13.9	26.79	Not reported	Not reported	Not reported

Extension Phase C19 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	51
Placebo	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-1.6	18.78	Not reported	Not reported	Not reported
Placebo	-16.7	14.43	Not reported	Not reported	Not reported

Extension Phase C21 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	45
Placebo	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	3.1	18.32	Not reported	Not reported	Not reported
Placebo	4.2	17.68	Not reported	Not reported	Not reported

Extension Phase C23 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	38
Placebo	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	0.9	17.84	Not reported	Not reported	Not reported
Placebo	16.7	NA	Not reported	Not reported	No standard deviation could be determined because a single participant was analyzed

Extension Phase C25 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	37
Placebo	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.0	18.15	Not reported	Not reported	Not reported
Placebo	16.7	NA	Not reported	Not reported	No standard deviation could be determined because a single participant was analyzed

Extension Phase C27 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	37
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	2.5	20.40	Not reported	Not reported	Not reported

Extension Phase C29 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	36
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	2.1	21.12	Not reported	Not reported	Not reported

Extension Phase C31 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	33
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-0.3	15.93	Not reported	Not reported	Not reported

Extension Phase C33 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	34
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-1.5	19.41	Not reported	Not reported	Not reported

Extension Phase C35 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	30
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	3.6	23.33	Not reported	Not reported	Not reported

Extension Phase C37 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	31
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	0.5	22.04	Not reported	Not reported	Not reported

Extension Phase C39 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	26
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	0.3	23.63	Not reported	Not reported	Not reported

Extension Phase C41 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	24
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	6.6	20.11	Not reported	Not reported	Not reported

Extension Phase C43 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	19
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	4.8	15.29	Not reported	Not reported	Not reported

Extension Phase C45 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	15
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-2.2	21.24	Not reported	Not reported	Not reported

Extension Phase C47 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	12
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	1.4	19.08	Not reported	Not reported	Not reported

Extension Phase C49 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	11
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-3.8	16.40	Not reported	Not reported	Not reported

Extension Phase C51 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	3
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	8.3	8.33	Not reported	Not reported	Not reported

Extension Phase C53 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	4
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	12.5	10.76	Not reported	Not reported	Not reported

Extension Phase C55 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	3
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	2.8	17.35	Not reported	Not reported	Not reported

Extension Phase C57 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	2
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	12.5	5.89	Not reported	Not reported	Not reported

Extension Phase C59 D1

Analysis denominator · Participants

Group	Source count
Luspatercept	1
Placebo	0

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	16.7	NA	Not reported	Not reported	No standard deviation could be determined because a single participant was analyzed

End of Treatment

Analysis denominator · Participants

Group	Source count
Luspatercept	88
Placebo	33

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	-9.2	23.97	Not reported	Not reported	Not reported
Placebo	-0.8	23.07	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
21.01
value
-4.1
group Id
OG001
spread
15.95
value
0.1
denoms
counts
group Id
OG000
value
133
group Id
OG001
value
69
units
Participants
title
Cycle 3 Day 1 (C3 D1)
categories
measurements
group Id
OG000
spread
20.73
value
-2.4
group Id
OG001
spread
17.13
value
2.2
denoms
counts
group Id
OG000
value
129
group Id
OG001
value
65
units
Participants
title
C5 D1
categories
measurements
group Id
OG000
spread
23.04
value
-2.1
group Id
OG001
spread
18.63
value
-0.6
denoms
counts
group Id
OG000
value
108
group Id
OG001
value
59
units
Participants
title
C7 D1
categories
measurements
group Id
OG000
spread
21.75
value
-1.8
group Id
OG001
spread
18.88
value
0.2
denoms
counts
group Id
OG000
value
110
group Id
OG001
value
53
units
Participants
title
Week 25
categories
measurements
group Id
OG000
spread
25.32
value
0.0
group Id
OG001
spread
14.60
value
6.3
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
8
units
Participants
title
Extension Phase C1 D1
categories
measurements
group Id
OG000
spread
19.68
value
2.0
group Id
OG001
spread
26.86
value
-3.9
denoms
counts
group Id
OG000
value
83
group Id
OG001
value
17
units
Participants
title
Extension Phase C3 D1
categories
measurements
group Id
OG000
spread
18.40
value
0.8
group Id
OG001
spread
20.04
value
0.6
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
15
units
Participants
title
Extension Phase C5 D1
categories
measurements
group Id
OG000
spread
20.03
value
-0.5
group Id
OG001
spread
20.87
value
3.8
denoms
counts
group Id
OG000
value
74
group Id
OG001
value
13
units
Participants
title
Extension Phase C7 D1
categories
measurements
group Id
OG000
spread
18.42
value
-2.4
group Id
OG001
spread
19.75
value
11.9
denoms
counts
group Id
OG000
value
69
group Id
OG001
value
7
units
Participants
title
Extension Phase C9 D1
categories
measurements
group Id
OG000
spread
19.53
value
-1.8
group Id
OG001
spread
24.47
value
4.8
denoms
counts
group Id
OG000
value
60
group Id
OG001
value
7
units
Participants
title
Extension Phase C11 D1
categories
measurements
group Id
OG000
spread
20.84
value
-2.6
group Id
OG001
spread
24.15
value
8.3
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
6
units
Participants
title
Extension Phase C13 D1
categories
measurements
group Id
OG000
spread
18.27
value
3.1
group Id
OG001
spread
27.26
value
4.2
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
6
units
Participants
title
Extension Phase C15 D1

denoms

counts
group Id
OG000
value
149
group Id
OG001
value
76
units
Participants

description

The EORTC questionnaire is a validated health-related quality of life (HRQoL) measure applicable to participants with any cancer diagnosis. Version 3.0 of the questionnaire was used in the study. It is composed of 30 items that address 15 domains, including one global health status, functional domains, and symptom domains. Domain scores are transformed to a 0 to 100 scale, where higher scores on the global quality of life score indicate better function. As such, a positive change from Baseline score indicates an improvement in quality of life.

dispersion Type

Standard Deviation

groups

description
Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
id
OG000
title
Luspatercept
description
Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
id
OG001
title
Placebo

param Type

MEAN

population Description

All treated participants who completed the EORTC QLQ-C30 assessment at baseline and at least one post-baseline assessment visit.

reporting Status

POSTED

time Frame

Baseline and Cycle 3, Day 1 (C3 D1), C5 D1, C7 D1, Week 25, every other cycle during extension phase (C1 D1, C3 D1, C5 D1, etc. up to C59 D1) and end of treatment. Each cycle is composed of 21 days.

title

Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Score

type

SECONDARY

unit Of Measure

Score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice