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NCT03112603 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

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; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)

What was measured

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.

Analysis population: FAS. Only participants with available data were analyzed.

Groups in this outcome

Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

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
Ruxolitinib	165
Best Available Therapy	164

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	122
Best Available Therapy	102

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	2.32	12.191	Not reported	Not reported	Not reported
Best Available Therapy	-0.22	14.949	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	115
Best Available Therapy	106

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.62	14.452	Not reported	Not reported	Not reported
Best Available Therapy	-1.82	15.849	Not reported	Not reported	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	110
Best Available Therapy	100

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	1.98	15.888	Not reported	Not reported	Not reported
Best Available Therapy	-1.05	16.147	Not reported	Not reported	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	107
Best Available Therapy	91

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	1.25	14.577	Not reported	Not reported	Not reported
Best Available Therapy	-0.23	18.903	Not reported	Not reported	Not reported

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	96
Best Available Therapy	85

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	2.91	14.562	Not reported	Not reported	Not reported
Best Available Therapy	2.41	14.766	Not reported	Not reported	Not reported

Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	90
Best Available Therapy	88

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	4.14	14.669	Not reported	Not reported	Not reported
Best Available Therapy	0.85	16.811	Not reported	Not reported	Not reported

Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	88
Best Available Therapy	46

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	5.32	16.815	Not reported	Not reported	Not reported
Best Available Therapy	1.20	17.635	Not reported	Not reported	Not reported

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	68
Best Available Therapy	35

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	7.26	19.296	Not reported	Not reported	Not reported
Best Available Therapy	3.74	18.059	Not reported	Not reported	Not reported

Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	59
Best Available Therapy	31

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	5.07	18.220	Not reported	Not reported	Not reported
Best Available Therapy	7.58	17.063	Not reported	Not reported	Not reported

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	55
Best Available Therapy	27

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	4.10	19.440	Not reported	Not reported	Not reported
Best Available Therapy	8.19	17.993	Not reported	Not reported	Not reported

Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	56
Best Available Therapy	24

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	5.24	19.485	Not reported	Not reported	Not reported
Best Available Therapy	3.68	17.378	Not reported	Not reported	Not reported

Cycle 24 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	50
Best Available Therapy	23

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	5.90	19.662	Not reported	Not reported	Not reported
Best Available Therapy	7.84	18.561	Not reported	Not reported	Not reported

Cycle 27 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	50
Best Available Therapy	21

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	6.23	18.880	Not reported	Not reported	Not reported
Best Available Therapy	5.10	18.885	Not reported	Not reported	Not reported

Cycle 30 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	48
Best Available Therapy	19

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	7.53	20.314	Not reported	Not reported	Not reported
Best Available Therapy	5.75	21.037	Not reported	Not reported	Not reported

Cycle 33 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	49
Best Available Therapy	19

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	5.17	20.330	Not reported	Not reported	Not reported
Best Available Therapy	5.67	22.573	Not reported	Not reported	Not reported

Cycle 36 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	47
Best Available Therapy	18

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	8.72	18.710	Not reported	Not reported	Not reported
Best Available Therapy	4.77	24.186	Not reported	Not reported	Not reported

Cycle 39 Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	50
Best Available Therapy	18

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	8.65	21.669	Not reported	Not reported	Not reported
Best Available Therapy	6.64	22.384	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12.191
value
2.32
group Id
OG001
spread
14.949
value
-0.22
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
102
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
14.452
value
0.62
group Id
OG001
spread
15.849
value
-1.82
denoms
counts
group Id
OG000
value
115
group Id
OG001
value
106
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
15.888
value
1.98
group Id
OG001
spread
16.147
value
-1.05
denoms
counts
group Id
OG000
value
110
group Id
OG001
value
100
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
14.577
value
1.25
group Id
OG001
spread
18.903
value
-0.23
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
91
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
14.562
value
2.91
group Id
OG001
spread
14.766
value
2.41
denoms
counts
group Id
OG000
value
96
group Id
OG001
value
85
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
14.669
value
4.14
group Id
OG001
spread
16.811
value
0.85
denoms
counts
group Id
OG000
value
90
group Id
OG001
value
88
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
16.815
value
5.32
group Id
OG001
spread
17.635
value
1.20
denoms
counts
group Id
OG000
value
88
group Id
OG001
value
46
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
19.296
value
7.26
group Id
OG001
spread
18.059
value
3.74
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
35
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
spread
18.220
value
5.07
group Id
OG001
spread
17.063
value
7.58
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
31
units
Participants
title
Cycle 15 Day 1
categories
measurements
group Id
OG000
spread
19.440
value
4.10
group Id
OG001
spread
17.993
value
8.19
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
27
units
Participants
title
Cycle 18 Day 1
categories
measurements
group Id
OG000
spread
19.485
value
5.24
group Id
OG001
spread
17.378
value
3.68
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
24
units
Participants
title
Cycle 21 Day 1
categories
measurements
group Id
OG000
spread
19.662
value
5.90
group Id
OG001
spread
18.561
value
7.84
denoms
counts
group Id
OG000
value
50
group Id
OG001
value
23
units
Participants
title
Cycle 24 Day 1

denoms

counts
group Id
OG000
value
165
group Id
OG001
value
164
units
Participants

description

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.

dispersion Type

Standard Deviation

groups

description
Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
id
OG000
title
Ruxolitinib
description
Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
id
OG001
title
Best Available Therapy

param Type

MEAN

population Description

FAS. Only participants with available data were analyzed.

reporting Status

POSTED

time Frame

Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)

title

Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)

type

SECONDARY

unit Of Measure

scores on a scale

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

Preserved source evidence · Not medical advice