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NCT01943851 · OUTCOME

Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 36.4 weeks

What was measured

Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, Prothrombin international normalized ratio (Pro. INR), albumin, amylase, ALT, AST, bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, Triglycerides, ALP. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.

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 75 mg QD MDS

Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 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	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Reported measurements

Glucose, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	6	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	14	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Pro.INR, n=4,13,0

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	4
Part 2: GSK525762 75 mg QD MDS	13
Part 2: GSK525762 80 mg QD CTCL	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	5	Not reported	Not reported	Not reported	Not reported

Albumin, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	9	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

ALT, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	4	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	4	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Amylase, n=7,15,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	15
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	3	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

AST, n=7,15,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	15
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	3	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	6	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Bilirubin, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	3	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	10	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Calcium, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Calcium Ionized, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	9	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Cholesterol, n=7,15,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	15
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Creatine Kinase, n=5,11,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	5
Part 2: GSK525762 75 mg QD MDS	11
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Creatinine, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	4	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Lipase, n=7,13,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	13
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Potassium, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	8	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Magnesium, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	7	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Sodium, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	4	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	6	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	1	Not reported	Not reported	Not reported	Not reported

Triglycerides, n=7,15,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	15
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	7	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	6	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

ALP, n=7,16,1

Analysis denominator · Participants

Group	Source count
Part 2: GSK525762 60 mg QD CTCL	7
Part 2: GSK525762 75 mg QD MDS	16
Part 2: GSK525762 80 mg QD CTCL	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK525762 60 mg QD CTCL	2	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 75 mg QD MDS	1	Not reported	Not reported	Not reported	Not reported
Part 2: GSK525762 80 mg QD CTCL	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
14
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Glucose, n=7,16,1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
13
group Id
OG002
value
0
units
Participants
title
Pro.INR, n=4,13,0
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
9
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Albumin, n=7,16,1
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
ALT, n=7,16,1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
15
group Id
OG002
value
1
units
Participants
title
Amylase, n=7,15,1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
15
group Id
OG002
value
1
units
Participants
title
AST, n=7,15,1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
10
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Bilirubin, n=7,16,1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Calcium, n=7,16,1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
9
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Calcium Ionized, n=7,16,1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
15
group Id
OG002
value
1
units
Participants
title
Cholesterol, n=7,15,1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
1
units
Participants
title
Creatine Kinase, n=5,11,1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants
title
Creatinine, n=7,16,1

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
16
group Id
OG002
value
1
units
Participants

description

Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, Prothrombin international normalized ratio (Pro. INR), albumin, amylase, ALT, AST, bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, Triglycerides, ALP. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.

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 with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
id
OG001
title
Part 2: GSK525762 75 mg QD MDS
description
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
id
OG002
title
Part 2: GSK525762 80 mg QD CTCL

param Type

COUNT_OF_PARTICIPANTS

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

Up to 36.4 weeks

title

Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice