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NCT01587703 · OUTCOME

Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

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: Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression

What was measured

Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

Analysis population: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Groups in this outcome

Part 1: GSK525762 20 mg BID

Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.

Part 1: GSK525762 30 mg BID

Participants were administered twice daily oral dose of 30 mg GSK525762.

Part 1: GSK525762 40 mg BID

Participants were administered once daily oral dose of 40 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 1: GSK525762 20 mg BID	4
Part 1: GSK525762 30 mg BID	10
Part 1: GSK525762 40 mg BID	5

Reported measurements

Glucose; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Glucose; Week 9;n=0,4,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	4
Part 1: GSK525762 40 mg BID	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Glucose; Week 17;n=0,2,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	2
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

Glucose; disc/prog;n=0,6,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	6
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Ketones; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Ketones; Week 17;n=0,2,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	2
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

Occult blood; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Occult blood; Week 9;n=0,4,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	4
Part 1: GSK525762 40 mg BID	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Occult blood; disc/prog;n=0,6,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	6
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

pH; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	2	Not reported	Not reported	Not reported	Not reported

pH; Week 9;n=0,4,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	4
Part 1: GSK525762 40 mg BID	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

pH; Week 17;n=0,2,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	2
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

pH; disc/prog;n=0,7,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Protein; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Protein; Week 9;n=0,4,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	4
Part 1: GSK525762 40 mg BID	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Protein; Week 17;n=0,2,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	2
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	2	Not reported	Not reported	Not reported	Not reported

Protein; disc/prog;n=0,7,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Erythrocytes; Week 5;n=1,5,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	1
Part 1: GSK525762 30 mg BID	5
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Erythrocytes; Week 9;n=0,1,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	1
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Erythrocytes; Week 17;n=0,1,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	1
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

Specific gravity; Week 5;n=2,7,3

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	2	Not reported	Not reported	Not reported	Not reported

Specific gravity; Week 9;n=0,4,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	4
Part 1: GSK525762 40 mg BID	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Specific gravity; Week 17;n=0,2,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	2
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

Specific gravity; disc/prog;n=0,7,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	7
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	0	Not reported	Not reported	Not reported	Not reported

Leukocytes; Week 5;n=1,5,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	1
Part 1: GSK525762 30 mg BID	5
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 20 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg BID	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Leukocytes; Week 9;n=0,1,1

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	1
Part 1: GSK525762 40 mg BID	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Leukocytes; Week 17;n=0,1,0

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	0
Part 1: GSK525762 30 mg BID	1
Part 1: GSK525762 40 mg BID	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 30 mg BID	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
3
units
Participants
title
Glucose; Week 5;n=2,7,3
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
2
units
Participants
title
Glucose; Week 9;n=0,4,2
categories
measurements
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
units
Participants
title
Glucose; Week 17;n=0,2,0
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
6
group Id
OG002
value
1
units
Participants
title
Glucose; disc/prog;n=0,6,1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
3
units
Participants
title
Ketones; Week 5;n=2,7,3
categories
measurements
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
units
Participants
title
Ketones; Week 17;n=0,2,0
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
3
units
Participants
title
Occult blood; Week 5;n=2,7,3
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
2
units
Participants
title
Occult blood; Week 9;n=0,4,2
categories
measurements
group Id
OG001
value
2
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
6
group Id
OG002
value
1
units
Participants
title
Occult blood; disc/prog;n=0,6,1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
3
units
Participants
title
pH; Week 5;n=2,7,3
categories
measurements
group Id
OG001
value
4
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
2
units
Participants
title
pH; Week 9;n=0,4,2
categories
measurements
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
units
Participants
title
pH; Week 17;n=0,2,0

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants

description

Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

groups

description
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
id
OG000
title
Part 1: GSK525762 20 mg BID
description
Participants were administered twice daily oral dose of 30 mg GSK525762.
id
OG001
title
Part 1: GSK525762 30 mg BID
description
Participants were administered once daily oral dose of 40 mg GSK525762.
id
OG002
title
Part 1: GSK525762 40 mg BID

param Type

COUNT_OF_PARTICIPANTS

population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

reporting Status

POSTED

time Frame

Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression

title

Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice