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NCT02038036 · OUTCOME

Spleen Length by 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: cm
Interval / dispersion: Standard Deviation
Time frame: 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

Spleen length was assessed by manual palpation at every study visit.

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 were not collected.

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	71
Best Available Therapy (BAT)	73

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.04	0.351	Not reported	Not reported	Not reported

Week 8

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.01	0.119	Not reported	Not reported	Not reported

Week 12

Analysis denominator · Participants

Group	Source count
Ruxolitinib	69
Best Available Therapy (BAT)	70

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.01	0.120	Not reported	Not reported	Not reported

Week 16

Analysis denominator · Participants

Group	Source count
Ruxolitinib	69
Best Available Therapy (BAT)	70

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.23	1.010	Not reported	Not reported	Not reported

Week 20

Analysis denominator · Participants

Group	Source count
Ruxolitinib	70
Best Available Therapy (BAT)	67

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.13	0.716	Not reported	Not reported	Not reported

Week 24

Analysis denominator · Participants

Group	Source count
Ruxolitinib	68
Best Available Therapy (BAT)	64

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.09	0.555	Not reported	Not reported	Not reported

Week 28

Analysis denominator · Participants

Group	Source count
Ruxolitinib	70
Best Available Therapy (BAT)	67

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.20	0.909	Not reported	Not reported	Not reported

Week 40

Analysis denominator · Participants

Group	Source count
Ruxolitinib	70
Best Available Therapy (BAT)	23

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.01	0.120	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.52	1.473	Not reported	Not reported	Not reported

Week 52

Analysis denominator · Participants

Group	Source count
Ruxolitinib	69
Best Available Therapy (BAT)	15

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.06	0.482	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.07	0.258	Not reported	Not reported	Not reported

Week 66

Analysis denominator · Participants

Group	Source count
Ruxolitinib	68
Best Available Therapy (BAT)	10

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.00	0.000	Not reported	Not reported	Not reported

Week 80

Analysis denominator · Participants

Group	Source count
Ruxolitinib	66
Best Available Therapy (BAT)	5

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.03	0.246	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0.00	0.000	Not reported	Not reported	Not reported

Week 92

Analysis denominator · Participants

Group	Source count
Ruxolitinib	67
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported

Week 104

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.05	0.378	Not reported	Not reported	Not reported

Week 117

Analysis denominator · Participants

Group	Source count
Ruxolitinib	66
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.12	0.985	Not reported	Not reported	Not reported

Week 130

Analysis denominator · Participants

Group	Source count
Ruxolitinib	66
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.18	1.162	Not reported	Not reported	Not reported

Week 143

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.08	0.458	Not reported	Not reported	Not reported

Week 156

Analysis denominator · Participants

Group	Source count
Ruxolitinib	65
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.05	0.372	Not reported	Not reported	Not reported

Week 169

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.05	0.378	Not reported	Not reported	Not reported

Week 182

Analysis denominator · Participants

Group	Source count
Ruxolitinib	62
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.05	0.381	Not reported	Not reported	Not reported

Week 195

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported

Week 208

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported

Week 221

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.02	0.129	Not reported	Not reported	Not reported

Week 234

Analysis denominator · Participants

Group	Source count
Ruxolitinib	59
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.00	0.000	Not reported	Not reported	Not reported

Week 247

Analysis denominator · Participants

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

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.02	0.136	Not reported	Not reported	Not reported

Week 260

Analysis denominator · Participants

Group	Source count
Ruxolitinib	42
Best Available Therapy (BAT)	0

Values in cm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.10	0.617	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.351
value
0.04
denoms
counts
group Id
OG000
value
71
group Id
OG001
value
73
units
Participants
title
Week 4
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.119
value
0.01
denoms
counts
group Id
OG000
value
71
group Id
OG001
value
71
units
Participants
title
Week 8
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.120
value
0.01
denoms
counts
group Id
OG000
value
69
group Id
OG001
value
70
units
Participants
title
Week 12
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
1.010
value
0.23
denoms
counts
group Id
OG000
value
69
group Id
OG001
value
70
units
Participants
title
Week 16
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.716
value
0.13
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
67
units
Participants
title
Week 20
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.555
value
0.09
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
64
units
Participants
title
Week 24
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.909
value
0.20
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
67
units
Participants
title
Week 28
categories
measurements
group Id
OG000
spread
0.120
value
0.01
group Id
OG001
spread
1.473
value
0.52
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
23
units
Participants
title
Week 40
categories
measurements
group Id
OG000
spread
0.482
value
0.06
group Id
OG001
spread
0.258
value
0.07
denoms
counts
group Id
OG000
value
69
group Id
OG001
value
15
units
Participants
title
Week 52
categories
measurements
group Id
OG000
spread
0.000
value
0.00
group Id
OG001
spread
0.000
value
0.00
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
10
units
Participants
title
Week 66
categories
measurements
group Id
OG000
spread
0.246
value
0.03
group Id
OG001
spread
0.000
value
0.00
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
5
units
Participants
title
Week 80
categories
measurements
group Id
OG000
spread
0.000
value
0.00
denoms
counts
group Id
OG000
value
67
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

Spleen length was assessed by manual palpation at every study visit.

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 were not collected.

reporting Status

POSTED

time Frame

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

Spleen Length by Visit

type

SECONDARY

unit Of Measure

cm

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

Preserved source evidence · Not medical advice