Skip to content

TriangleGet started

← Full study record

NCT01587703 · OUTCOME

Number of Participants With Grade Change From Baseline in Clinical Chemistry 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 median of 1.41 months of drug exposure

What was measured

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. 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. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is 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 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 twice 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; Any grade increase; n=4, 10, 5

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

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	9	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	5	Not reported	Not reported	Not reported	Not reported

Glucose; Increase to Grade 3; n=4, 10, 5

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

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	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Glucose; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Albumin; Any grade increase; n=4, 10, 5

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

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

Albumin; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Albumin; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

ALP; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported

ALP; Increase to Grade 3; n=4, 10, 5

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

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

ALP; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

ALT; Any grade increase; n=4, 10, 5

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

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	5	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

ALT; Increase to Grade 3; n=4, 10, 5

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

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

ALT; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Amylase; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported

Amylase; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Amylase; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

AST; Any grade increase; n=4, 10, 5

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

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	6	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

AST; Increase to Grade 3; n=4, 10, 5

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

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

AST; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Dir bil; Any grade increase; n=4, 9, 4

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	4
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	4

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	0	Not reported	Not reported	Not reported	Not reported

Dir bil; Increase to Grade 3; n=4, 9, 4

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	4
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	4

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	0	Not reported	Not reported	Not reported	Not reported

Dir bil; Increase to Grade 4; n=4, 9, 4

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	4
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	4

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	0	Not reported	Not reported	Not reported	Not reported

Bilirubin; Any grade increase; n=4, 10, 5

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

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	7	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	2	Not reported	Not reported	Not reported	Not reported

Bilirubin; Increase to Grade 3; n=4, 10, 5

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

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	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Bilirubin; Increase to Grade 4; n=4, 10, 5

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

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

NT-BNP; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

NT-BNP; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

NT-BNP; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Calcium; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	1	Not reported	Not reported	Not reported	Not reported

Calcium; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Calcium; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Cholesterol; Any grade increase; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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

Cholesterol; Increase to Grade 3; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Cholesterol; Increase to Grade 4; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

CK; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported

CK; Increase to Grade 3; n=n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

CK; Increase to Grade 4; n=n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Chloride; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Chloride; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Chloride; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

CO2; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

CO2; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

CO2; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Creatinine; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported

Creatinine; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Creatinine; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

GGT; Any grade increase; n=4, 10, 5

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

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

GGT; Increase to Grade 3; n=4, 10, 5

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

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

GGT; Increase to Grade 4; n=4, 10, 5

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

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

HDL; Any grade increase; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

HDL; Increase to Grade 3; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

HDL; Increase to Grade 4; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Insulin; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Insulin; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Insulin; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Potassium; Any grade increase; n=4, 10, 5

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

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	5	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	2	Not reported	Not reported	Not reported	Not reported

Potassium; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Potassium; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

LDL; Any grade increase; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

LDL; Increase to Grade 3; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

LDL; Increase to Grade 4; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Lipase; Any grade increase; n=4, 10, 5

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

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	3	Not reported	Not reported	Not reported	Not reported

Lipase; Increase to Grade 3; n=4, 10, 5

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

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

Lipase; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Magnesium; Any grade increase; n=4, 10, 5

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

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	2	Not reported	Not reported	Not reported	Not reported

Magnesium; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Magnesium; Increase to Grade 4; n=4, 10, 5

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

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

Protein; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Protein; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Protein; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Sodium; Any grade increase; n=4, 10, 5

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

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	7	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 40 mg BID	2	Not reported	Not reported	Not reported	Not reported

Sodium; Increase to Grade 3; n=4, 10, 5

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

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

Sodium; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Thyroxine; Any grade increase; n=3, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Thyroxine; Increase to Grade 3; n=3, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Thyroxine; Increase to Grade 4; n=3, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Testosterone; Any grade increase; n=1, 4, 4

Analysis denominator · Participants

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

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	0	Not reported	Not reported	Not reported	Not reported

Testosterone; Increase to Grade 3; n=1, 4, 4

Analysis denominator · Participants

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

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	0	Not reported	Not reported	Not reported	Not reported

Testosterone; Increase to Grade 4; n=1, 4, 4

Analysis denominator · Participants

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

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	0	Not reported	Not reported	Not reported	Not reported

Triglycerides; Any grade increase; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	4	Not reported	Not reported	Not reported	Not reported

Triglycerides; Increase to Grade 3; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Triglycerides; Increase to Grade 4; n=2, 9, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	2
Part 1: GSK525762 30 mg BID	9
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Troponin I; Any grade increase; n=3, 10, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	10
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Troponin I; Increase to Grade 3; n=3, 10, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	10
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Troponin I; Increase to Grade 4; n=3, 10, 5

Analysis denominator · Participants

Group	Source count
Part 1: GSK525762 20 mg BID	3
Part 1: GSK525762 30 mg BID	10
Part 1: GSK525762 40 mg BID	5

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	0	Not reported	Not reported	Not reported	Not reported

Troponin T; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Troponin T; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Troponin T; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urate; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urate; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urate; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urea; Any grade increase; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urea; Increase to Grade 3; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Urea; Increase to Grade 4; n=4, 10, 5

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

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	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
9
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Glucose; Any grade increase; n=4, 10, 5
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Glucose; Increase to Grade 3; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Glucose; Increase to Grade 4; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Albumin; Any grade increase; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Albumin; Increase to Grade 3; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
Albumin; Increase to Grade 4; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALP; Any grade increase; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALP; Increase to Grade 3; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALP; Increase to Grade 4; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALT; Any grade increase; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALT; Increase to Grade 3; n=4, 10, 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
10
group Id
OG002
value
5
units
Participants
title
ALT; Increase to Grade 4; n=4, 10, 5

denoms

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

description

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. 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. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.

groups

description
Participants were administered twice daily 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 twice 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 median of 1.41 months of drug exposure

title

Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice