Number of Participants With Grade Change From Baseline in Hematology 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 hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, 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 (indicated by n=X in category titles).
Groups in this outcome
Part 1: GSK525762 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg BID
Participants were administered once daily oral dose of 40 mg GSK525762.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 1: GSK525762 20 mg BID
4
Part 1: GSK525762 30 mg BID
10
Part 1: GSK525762 40 mg BID
5
Reported measurements
Basophils; Any grade increase; n=4,10,5
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
Basophils; Increase to Grade 3; n=4,10,5
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
Basophils; Increase to Grade 4; n=4,10,5
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
Eosinophils; Any grade increase; n=4,10,5
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
Eosinophils; Increase to Grade3; n=4,10,5
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
Eosinophils; Increase to Grade4; n=4,10,5
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
Hemoglobin; Any grade increase; n=4,10,5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: GSK525762 20 mg BID
4
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 30 mg BID
8
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 40 mg BID
4
Not reported
Not reported
Not reported
Not reported
Hemoglobin; Increase to Grade 3; n=4,10,5
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
Hemoglobin; Increase to Grade 4; n=4,10,5
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
INR; Any grade increase; n=4,10,5
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
6
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 40 mg BID
3
Not reported
Not reported
Not reported
Not reported
INR; Increase to Grade 3; n=4,10,5
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
INR; Increase to Grade 4; n=4,10,5
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
Lymphocytes; Any grade increase; n=4,10,5
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
8
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 40 mg BID
2
Not reported
Not reported
Not reported
Not reported
Lymphocytes; Increase to Grade3; n=4,10,5
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
0
Not reported
Not reported
Not reported
Not reported
Lymphocytes; Increase to Grade4; n=4,10,5
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
Monocytes; Any grade increase; n=4,10,5
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
Monocytes;Increase to Grade3; n=4,10,5
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
Monocytes; Increase to Grade 4; n=4,10,5
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
Neutrophils; Any grade increase; n=4,10,5
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
1
Not reported
Not reported
Not reported
Not reported
Neutrophils; Increase to Grade 3; n=4,10,5
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
Neutrophils; Increase to Grade 4; n=4,10,5
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
Platelets; Any grade increase; n=4,10,5
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
10
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 40 mg BID
5
Not reported
Not reported
Not reported
Not reported
Platelets; Increase to Grade 3; n=4,10,5
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
Platelets; Increase to Grade 4; n=4,10,5
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
1
Not reported
Not reported
Not reported
Not reported
PT; Any grade increase;n=4,10,5
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
PT; Increase to Grade 3; n=4,10,5
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
PT; Increase to Grade 4; n=4,10,5
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
RBC; Any grade increase; n=4,10,5
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
RBC; Increase to Grade 3; n=4,10,5
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
RBC; Increase to Grade 4; n=4,10,5
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
WBC; Any grade increase; n=4,10,5
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
0
Not reported
Not reported
Not reported
Not reported
Part 1: GSK525762 40 mg BID
1
Not reported
Not reported
Not reported
Not reported
WBC; Increase to Grade 3; n=4,10,5
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
WBC; Increase to Grade 4; n=4,10,5
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
Fib; Any grade increase; n=4,10,5
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
Fib; Increase to Grade 3; n=4,10,5
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
Fib; Increase to Grade 4; n=4,10,5
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
aPTT; Any grade increase; n=4,10,5
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
2
Not reported
Not reported
Not reported
Not reported
aPTT; Increase to Grade 3; n=4,10,5
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
aPTT; Increase to Grade 4; n=4,10,5
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
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Basophils; Any grade increase; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Basophils; 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
title
Basophils; Increase to Grade 4; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Eosinophils; Any grade increase; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Eosinophils; Increase to Grade3; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Eosinophils; Increase to Grade4; n=4,10,5
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
8
group Id
OG002
value
4
title
Hemoglobin; Any grade increase; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
2
title
Hemoglobin; 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
title
Hemoglobin; Increase to Grade 4; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
6
group Id
OG002
value
3
title
INR; Any grade increase; n=4,10,5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
INR; 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
title
INR; 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 hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, 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.
groups
description
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
id
OG000
title
Part 1: GSK525762 20 mg BID
description
Participants were administered twice daily oral dose of 30 mg GSK525762.
id
OG001
title
Part 1: GSK525762 30 mg BID
description
Participants were administered once daily oral dose of 40 mg GSK525762.
id
OG002
title
Part 1: GSK525762 40 mg BID
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
reporting Status
POSTED
time Frame
Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
title
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Triangle