NCT01587703 · OUTCOME

Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD

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 1.38 months of drug exposure

What was measured

Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. 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.

Groups in this outcome

Part 1: GSK525762 2 mg QD

Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.

Part 1: GSK525762 4 mg QD

Participants were administered once daily oral dose of 4 mg GSK525762.

Part 1: GSK525762 8 mg QD

Participants were administered once daily oral dose of 8 mg GSK525762.

Part 1: GSK525762 16 mg QD

Participants were administered once daily oral dose of 16 mg GSK525762.

Part 1: GSK525762 30 mg QD

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

Part 1: GSK525762 60 mg QD

Participants were administered once daily oral dose of 60 mg GSK525762.

Part 1: GSK525762 80 mg QD

Participants were administered once daily oral dose of 80 mg GSK525762.

Part 1: GSK525762 100 mg QD

Participants were administered once daily oral dose of 100 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 2 mg QD	2
Part 1: GSK525762 4 mg QD	4
Part 1: GSK525762 8 mg QD	1
Part 1: GSK525762 16 mg QD	3
Part 1: GSK525762 30 mg QD	4
Part 1: GSK525762 60 mg QD	9
Part 1: GSK525762 80 mg QD	32
Part 1: GSK525762 100 mg QD	9

Reported measurements

Basophils;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Basophils;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Basophils;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Eosinophils;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Eosinophils;Increase to Grade3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Eosinophils;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Hemoglobin;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	21	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	7	Not reported	Not reported	Not reported	Not reported

Hemoglobin;Increase to Grade 3; n=2,4,1,3,4,9,32,9

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	9	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	1	Not reported	Not reported	Not reported	Not reported

Hemoglobin;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

INR; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	21	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	2	Not reported	Not reported	Not reported	Not reported

INR;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

INR; Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Lymphocytes;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	5	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	19	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	4	Not reported	Not reported	Not reported	Not reported

Lymphocytes;Increase to Grade3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	8	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	1	Not reported	Not reported	Not reported	Not reported

Lymphocytes;Increase to Grade4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	1	Not reported	Not reported	Not reported	Not reported

Monocytes;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Monocytes;Increase to Grade3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	00	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	0	Not reported	Not reported	Not reported	Not reported

Monocytes;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Neutrophils;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	7	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	3	Not reported	Not reported	Not reported	Not reported

Neutrophils;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	1	Not reported	Not reported	Not reported	Not reported

Neutrophils;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	0	Not reported	Not reported	Not reported	Not reported

Platelets;Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	5	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	26	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	8	Not reported	Not reported	Not reported	Not reported

Platelets;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	11	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	5	Not reported	Not reported	Not reported	Not reported

Platelets;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	5	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	2	Not reported	Not reported	Not reported	Not reported

PT; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

PT; Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

PT; Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

RBC; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

RBC;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

RBC;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

WBC; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	11	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	5	Not reported	Not reported	Not reported	Not reported

WBC; Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	1	Not reported	Not reported	Not reported	Not reported

WBC; Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	0	Not reported	Not reported	Not reported	Not reported

Fib; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	0	Not reported	Not reported	Not reported	Not reported

Fib;Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

Fib;Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	Not reported	Not reported	Not reported	Not reported

aPTT; Any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	14	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	2	Not reported	Not reported	Not reported	Not reported

aPTT; Increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	0	Not reported	Not reported	Not reported	Not reported

aPTT; Increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK525762 2 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 4 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 8 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 16 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 30 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 60 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 80 mg QD	Not reported	Not reported	Not reported	Not reported
Part 1: GSK525762 100 mg QD	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
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Basophils;Any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Basophils;Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Basophils;Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Eosinophils;Any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Eosinophils;Increase to Grade3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Eosinophils;Increase to Grade 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
21
group Id
OG007
value
7
title
Hemoglobin;Any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
9
group Id
OG007
value
1
title
Hemoglobin;Increase to Grade 3; n=2,4,1,3,4,9,32,9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
Hemoglobin;Increase to Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
21
group Id
OG007
value
2
title
INR; Any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
INR;Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
title
INR; Increase to Grade 4

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
9
group Id
OG006
value
32
group Id
OG007
value
9
units
Participants

description

groups

description
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
id
OG000
title
Part 1: GSK525762 2 mg QD
description
Participants were administered once daily oral dose of 4 mg GSK525762.
id
OG001
title
Part 1: GSK525762 4 mg QD
description
Participants were administered once daily oral dose of 8 mg GSK525762.
id
OG002
title
Part 1: GSK525762 8 mg QD
description
Participants were administered once daily oral dose of 16 mg GSK525762.
id
OG003
title
Part 1: GSK525762 16 mg QD
description
Participants were administered once daily oral dose of 30 mg GSK525762.
id
OG004
title
Part 1: GSK525762 30 mg QD
description
Participants were administered once daily oral dose of 60 mg GSK525762.
id
OG005
title
Part 1: GSK525762 60 mg QD
description
Participants were administered once daily oral dose of 80 mg GSK525762.
id
OG006
title
Part 1: GSK525762 80 mg QD
description
Participants were administered once daily oral dose of 100 mg GSK525762.
id
OG007
title
Part 1: GSK525762 100 mg QD

param Type

COUNT_OF_PARTICIPANTS

population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed.

reporting Status

POSTED

time Frame

Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

title

Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice