Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01
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 (pre-dose Week1 Day1) and Week 3, Week 7, Week 10, Week 16 and Week 24
What was measured
The effects of treatment on disease-related symptoms/quality of life was assessed using the Skindex-29 Questionnaire, which inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous 4 weeks the participant experienced the effect described in each of 29 items divided into 3 domains: Emotional (10 items), Symptoms (7 items) and Functioning (12 items). Responses to each item are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex-29 scores were reported as three individual domain scale scores; a scale score is the mean of a participant's responses to items in a given domain. Each domain score ranges from 0 (no effect) to 100 (effect experienced all the time), higher score implies higher impact of skin disease. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is defined is post-dose visit value minus Baseline.
Analysis population: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Groups in this outcome
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
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
Part 2: GSK525762 60 mg QD CTCL
6
Part 2: GSK525762 80 mg QD CTCL
1
Reported measurements
Emotional score, Week 3, n=6,1
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
6
Part 2: GSK525762 80 mg QD CTCL
1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-5.83
15.221
Not reported
Not reported
Not reported
Part 2: GSK525762 80 mg QD CTCL
9.17
NA
Not reported
Not reported
Standard deviation could not be calculated for a single participant
Emotional score, Week 7, n=5,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
5
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-19.50
22.735
Not reported
Not reported
Not reported
Emotional score, Week 10, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-44.17
26.497
Not reported
Not reported
Not reported
Emotional score, Week 16, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-10.00
10.897
Not reported
Not reported
Not reported
Emotional score, Week 24, n=2,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
2
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-18.75
1.768
Not reported
Not reported
Not reported
Functioning score, Week 3, n=6,1
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
6
Part 2: GSK525762 80 mg QD CTCL
1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-1.42
7.742
Not reported
Not reported
Not reported
Part 2: GSK525762 80 mg QD CTCL
30.87
NA
Not reported
Not reported
Standard deviation could not be calculated for a single participant
Functioning score, Week 7, n=5,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
5
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-13.37
23.000
Not reported
Not reported
Not reported
Functioning score, Week 10, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-35.67
27.820
Not reported
Not reported
Not reported
Functioning score, Week 16, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-13.45
9.788
Not reported
Not reported
Not reported
Functioning score, Week 24, n=2,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
2
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-18.84
11.919
Not reported
Not reported
Not reported
Symptoms score, Week 3, n=6,1
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
6
Part 2: GSK525762 80 mg QD CTCL
1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
6.55
24.055
Not reported
Not reported
Not reported
Part 2: GSK525762 80 mg QD CTCL
12.50
NA
Not reported
Not reported
Standard deviation could not be calculated for a single participant
Symptoms score, Week 7, n=5,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
5
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-2.14
18.489
Not reported
Not reported
Not reported
Symptoms score, Week 10, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-29.76
20.927
Not reported
Not reported
Not reported
Symptoms score, Week 16, n=3,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
3
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-8.33
19.670
Not reported
Not reported
Not reported
Symptoms score, Week 24, n=2,0
Analysis denominator · Participants
Group
Source count
Part 2: GSK525762 60 mg QD CTCL
2
Part 2: GSK525762 80 mg QD CTCL
0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK525762 60 mg QD CTCL
-14.29
10.102
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
15.221
value
-5.83
comment
Standard deviation could not be calculated for a single participant
group Id
OG001
spread
NA
value
9.17
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
1
units
Participants
title
Emotional score, Week 3, n=6,1
categories
measurements
group Id
OG000
spread
22.735
value
-19.50
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
0
units
Participants
title
Emotional score, Week 7, n=5,0
categories
measurements
group Id
OG000
spread
26.497
value
-44.17
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants
title
Emotional score, Week 10, n=3,0
categories
measurements
group Id
OG000
spread
10.897
value
-10.00
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants
title
Emotional score, Week 16, n=3,0
categories
measurements
group Id
OG000
spread
1.768
value
-18.75
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
units
Participants
title
Emotional score, Week 24, n=2,0
categories
measurements
group Id
OG000
spread
7.742
value
-1.42
comment
Standard deviation could not be calculated for a single participant
group Id
OG001
spread
NA
value
30.87
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
1
units
Participants
title
Functioning score, Week 3, n=6,1
categories
measurements
group Id
OG000
spread
23.000
value
-13.37
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
0
units
Participants
title
Functioning score, Week 7, n=5,0
categories
measurements
group Id
OG000
spread
27.820
value
-35.67
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants
title
Functioning score, Week 10, n=3,0
categories
measurements
group Id
OG000
spread
9.788
value
-13.45
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants
title
Functioning score, Week 16, n=3,0
categories
measurements
group Id
OG000
spread
11.919
value
-18.84
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
units
Participants
title
Functioning score, Week 24, n=2,0
categories
measurements
group Id
OG000
spread
24.055
value
6.55
comment
Standard deviation could not be calculated for a single participant
group Id
OG001
spread
NA
value
12.50
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
1
units
Participants
title
Symptoms score, Week 3, n=6,1
categories
measurements
group Id
OG000
spread
18.489
value
-2.14
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
0
units
Participants
title
Symptoms score, Week 7, n=5,0
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
1
units
Participants
description
The effects of treatment on disease-related symptoms/quality of life was assessed using the Skindex-29 Questionnaire, which inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous 4 weeks the participant experienced the effect described in each of 29 items divided into 3 domains: Emotional (10 items), Symptoms (7 items) and Functioning (12 items). Responses to each item are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex-29 scores were reported as three individual domain scale scores; a scale score is the mean of a participant's responses to items in a given domain. Each domain score ranges from 0 (no effect) to 100 (effect experienced all the time), higher score implies higher impact of skin disease. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is defined is post-dose visit value minus Baseline.
dispersion Type
Standard Deviation
groups
description
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
id
OG000
title
Part 2: GSK525762 60 mg QD CTCL
description
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
id
OG001
title
Part 2: GSK525762 80 mg QD CTCL
param Type
MEAN
population Description
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
reporting Status
POSTED
time Frame
Baseline (pre-dose Week1 Day1) and Week 3, Week 7, Week 10, Week 16 and Week 24
title
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Triangle