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NCT02038036 · OUTCOME

Change From Baseline in Hematocrit (Hct) at Each Visit

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

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

Measure: MEAN
Unit: volume percentage of RBC in blood
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260

What was measured

Hematocrit is the volume percentage of red blood cells (RBC) in the blood.

Analysis population: Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT are reported as separate outcome measure.

Groups in this outcome

Ruxolitinib

Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

Best Available Therapy (BAT)

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib

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	74
Best Available Therapy (BAT)	75

Reported measurements

Week 4

Analysis denominator · Participants

Group	Source count
Ruxolitinib	67
Best Available Therapy (BAT)	69

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-0.65	2.943	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.25	2.994	Not reported	Not reported	Not reported

Week 8

Analysis denominator · Participants

Group	Source count
Ruxolitinib	67
Best Available Therapy (BAT)	71

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-1.22	3.634	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.63	3.344	Not reported	Not reported	Not reported

Week 12

Analysis denominator · Participants

Group	Source count
Ruxolitinib	65
Best Available Therapy (BAT)	71

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.33	4.581	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.70	3.485	Not reported	Not reported	Not reported

Week 16

Analysis denominator · Participants

Group	Source count
Ruxolitinib	66
Best Available Therapy (BAT)	70

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.25	4.179	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.83	3.439	Not reported	Not reported	Not reported

Week 20

Analysis denominator · Participants

Group	Source count
Ruxolitinib	68
Best Available Therapy (BAT)	68

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.05	4.307	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.45	3.984	Not reported	Not reported	Not reported

Week 24

Analysis denominator · Participants

Group	Source count
Ruxolitinib	64
Best Available Therapy (BAT)	63

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.85	4.094	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.52	2.934	Not reported	Not reported	Not reported

Week 28

Analysis denominator · Participants

Group	Source count
Ruxolitinib	65
Best Available Therapy (BAT)	67

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.60	4.101	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	2.09	3.852	Not reported	Not reported	Not reported

Week 40

Analysis denominator · Participants

Group	Source count
Ruxolitinib	67
Best Available Therapy (BAT)	24

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.77	4.538	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	2.05	4.587	Not reported	Not reported	Not reported

Week 52

Analysis denominator · Participants

Group	Source count
Ruxolitinib	65
Best Available Therapy (BAT)	16

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.49	4.445	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	1.68	4.854	Not reported	Not reported	Not reported

Week 66

Analysis denominator · Participants

Group	Source count
Ruxolitinib	63
Best Available Therapy (BAT)	11

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.06	4.573	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	2.73	2.922	Not reported	Not reported	Not reported

Week 80

Analysis denominator · Participants

Group	Source count
Ruxolitinib	61
Best Available Therapy (BAT)	6

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.20	3.886	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.62	4.436	Not reported	Not reported	Not reported

Week 92

Analysis denominator · Participants

Group	Source count
Ruxolitinib	64
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.91	4.203	Not reported	Not reported	Not reported

Week 104

Analysis denominator · Participants

Group	Source count
Ruxolitinib	61
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.19	4.314	Not reported	Not reported	Not reported

Week 117

Analysis denominator · Participants

Group	Source count
Ruxolitinib	63
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.86	4.540	Not reported	Not reported	Not reported

Week 130

Analysis denominator · Participants

Group	Source count
Ruxolitinib	63
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.13	4.263	Not reported	Not reported	Not reported

Week 143

Analysis denominator · Participants

Group	Source count
Ruxolitinib	60
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.50	3.463	Not reported	Not reported	Not reported

Week 156

Analysis denominator · Participants

Group	Source count
Ruxolitinib	61
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.54	4.005	Not reported	Not reported	Not reported

Week 169

Analysis denominator · Participants

Group	Source count
Ruxolitinib	58
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.57	4.477	Not reported	Not reported	Not reported

Week 182

Analysis denominator · Participants

Group	Source count
Ruxolitinib	58
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.94	4.428	Not reported	Not reported	Not reported

Week 195

Analysis denominator · Participants

Group	Source count
Ruxolitinib	58
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.36	4.515	Not reported	Not reported	Not reported

Week 208

Analysis denominator · Participants

Group	Source count
Ruxolitinib	55
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.23	4.150	Not reported	Not reported	Not reported

Week 221

Analysis denominator · Participants

Group	Source count
Ruxolitinib	54
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.55	4.413	Not reported	Not reported	Not reported

Week 234

Analysis denominator · Participants

Group	Source count
Ruxolitinib	56
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.31	4.621	Not reported	Not reported	Not reported

Week 247

Analysis denominator · Participants

Group	Source count
Ruxolitinib	52
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-3.45	4.053	Not reported	Not reported	Not reported

Week 260

Analysis denominator · Participants

Group	Source count
Ruxolitinib	40
Best Available Therapy (BAT)	0

Values in volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	-2.93	3.799	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.943
value
-0.65
group Id
OG001
spread
2.994
value
1.25
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
69
units
Participants
title
Week 4
categories
measurements
group Id
OG000
spread
3.634
value
-1.22
group Id
OG001
spread
3.344
value
1.63
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
71
units
Participants
title
Week 8
categories
measurements
group Id
OG000
spread
4.581
value
-2.33
group Id
OG001
spread
3.485
value
1.70
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
71
units
Participants
title
Week 12
categories
measurements
group Id
OG000
spread
4.179
value
-3.25
group Id
OG001
spread
3.439
value
1.83
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
70
units
Participants
title
Week 16
categories
measurements
group Id
OG000
spread
4.307
value
-3.05
group Id
OG001
spread
3.984
value
1.45
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
68
units
Participants
title
Week 20
categories
measurements
group Id
OG000
spread
4.094
value
-2.85
group Id
OG001
spread
2.934
value
1.52
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
63
units
Participants
title
Week 24
categories
measurements
group Id
OG000
spread
4.101
value
-2.60
group Id
OG001
spread
3.852
value
2.09
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
67
units
Participants
title
Week 28
categories
measurements
group Id
OG000
spread
4.538
value
-2.77
group Id
OG001
spread
4.587
value
2.05
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
24
units
Participants
title
Week 40
categories
measurements
group Id
OG000
spread
4.445
value
-2.49
group Id
OG001
spread
4.854
value
1.68
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
16
units
Participants
title
Week 52
categories
measurements
group Id
OG000
spread
4.573
value
-3.06
group Id
OG001
spread
2.922
value
2.73
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
11
units
Participants
title
Week 66
categories
measurements
group Id
OG000
spread
3.886
value
-3.20
group Id
OG001
spread
4.436
value
0.62
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
6
units
Participants
title
Week 80
categories
measurements
group Id
OG000
spread
4.203
value
-2.91
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
0
units
Participants
title
Week 92

denoms

counts
group Id
OG000
value
74
group Id
OG001
value
75
units
Participants

description

Hematocrit is the volume percentage of red blood cells (RBC) in the blood.

dispersion Type

Standard Deviation

groups

description
Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
id
OG000
title
Ruxolitinib
description
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
id
OG001
title
Best Available Therapy (BAT)

param Type

MEAN

population Description

Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT are reported as separate outcome measure.

reporting Status

POSTED

time Frame

Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260

title

Change From Baseline in Hematocrit (Hct) at Each Visit

type

SECONDARY

unit Of Measure

volume percentage of RBC in blood

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

Preserved source evidence · Not medical advice