NCT00952289 · BASELINE

Baseline characteristics

COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial · Source last updated 2018-03-12

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

denoms

counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants

groups

description
Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
id
BG000
title
Ruxolitinib
description
Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.82
value
66.7
group Id
BG001
spread
8.66
value
68.7
group Id
BG002
spread
8.78
value
67.7
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
65
group Id
BG002
value
141
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
153
group Id
BG002
value
308
units
Participants
title
Female
categories
measurements
group Id
BG000
value
79
group Id
BG001
value
88
group Id
BG002
value
167
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
153
group Id
BG002
value
308
units
Participants
title
Male
param Type
NUMBER
population Description
Gender data for one patient in the placebo arm was not available because of loss of study data during a move to a new location by the clinical site.
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
13
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
139
group Id
BG002
value
277
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
White
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Other
description
Race data for one patient in the placebo arm was not available because of loss of study data during a move to a new location by the clinical site.
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
84
group Id
BG002
value
154
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Primary myelofibrosis
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
47
group Id
BG002
value
97
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Post-polycythemia vera-myelofibrosis
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
22
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Post-essential thrombocythemia-myelofibrosis
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Missing
param Type
NUMBER
title
Disease Subtype
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
1247.0
value
2745.7
group Id
BG001
spread
1388.5
value
2797.6
group Id
BG002
spread
1317.3
value
2771.5
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
description
Spleen volume was measured by magnetic resonance imaging or computed tomography scans. Data for one patient in the placebo arm was not available because of loss of study data during a move by the clinical site.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Spleen volume
unit Of Measure
cm˄3
classes
categories
measurements
group Id
BG000
value
113
group Id
BG001
value
123
group Id
BG002
value
236
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
27
group Id
BG002
value
67
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Unknown/Missing
description
JAK2V617F is a mutation in the pseudokinase domain of Janus Kinase 2 (JAK2) (at amino acid 617, valine to phenylalanine) that results in constitutive activation of JAK2. Mutation status was determined using a validated assay on bone marrow as well as peripheral blood.
param Type
NUMBER
title
JAK2 V617F Mutation Status
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants

groups

description
Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
id
BG000
title
Ruxolitinib
description
Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.82
value
66.7
group Id
BG001
spread
8.66
value
68.7
group Id
BG002
spread
8.78
value
67.7
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
65
group Id
BG002
value
141
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
153
group Id
BG002
value
308
units
Participants
title
Female
categories
measurements
group Id
BG000
value
79
group Id
BG001
value
88
group Id
BG002
value
167
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
153
group Id
BG002
value
308
units
Participants
title
Male
param Type
NUMBER
population Description
Gender data for one patient in the placebo arm was not available because of loss of study data during a move to a new location by the clinical site.
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
13
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
139
group Id
BG002
value
277
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
White
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Other
description
Race data for one patient in the placebo arm was not available because of loss of study data during a move to a new location by the clinical site.
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
84
group Id
BG002
value
154
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Primary myelofibrosis
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
47
group Id
BG002
value
97
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Post-polycythemia vera-myelofibrosis
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
22
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Post-essential thrombocythemia-myelofibrosis
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Missing
param Type
NUMBER
title
Disease Subtype
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
1247.0
value
2745.7
group Id
BG001
spread
1388.5
value
2797.6
group Id
BG002
spread
1317.3
value
2771.5
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
description
Spleen volume was measured by magnetic resonance imaging or computed tomography scans. Data for one patient in the placebo arm was not available because of loss of study data during a move by the clinical site.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Spleen volume
unit Of Measure
cm˄3
classes
categories
measurements
group Id
BG000
value
113
group Id
BG001
value
123
group Id
BG002
value
236
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
27
group Id
BG002
value
67
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
155
group Id
BG001
value
154
group Id
BG002
value
309
units
Participants
title
Unknown/Missing
description
JAK2V617F is a mutation in the pseudokinase domain of Janus Kinase 2 (JAK2) (at amino acid 617, valine to phenylalanine) that results in constitutive activation of JAK2. Mutation status was determined using a validated assay on bone marrow as well as peripheral blood.
param Type
NUMBER
title
JAK2 V617F Mutation Status
unit Of Measure
participants

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Preserved source evidence · Not medical advice