NCT01587703 · OUTCOME
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study 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 1.87 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
Groups in this outcome 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Reported measurements Basophils; Any grade increase Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Basophils; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Basophils; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Eosinophils; Any grade increase Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Eosinophils; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Eosinophils; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported
Hemoglobin; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported
Hemoglobin; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
INR; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
INR; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 Not reported Not reported Not reported Not reported
Lymphocytes; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Lymphocytes; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Monocytes; Any grade increase Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Monocytes; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Monocytes; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
PT; Any grade increase Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
PT; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
PT; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
RBC; Any grade increase Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
RBC; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
RBC; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Fib; Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Fib; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
aPTT; Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 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
title Basophils; Any grade increase categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Basophils; Increase to Grade 3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Basophils; Increase to Grade 4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophils; Any grade increase categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophils; Increase to Grade 3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophils; Increase to Grade 4 categories measurements
group Id OG000
value 4
group Id OG001
value 3
title Hemoglobin; Any grade increase categories measurements
group Id OG000
value 2
group Id OG001
value 2
title Hemoglobin; Increase to Grade 3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Hemoglobin; Increase to Grade 4 categories measurements
group Id OG000
value 1
group Id OG001
value 1
title INR; Any grade increase categories measurements
group Id OG000
value 0
group Id OG001
value 0
title INR; Increase to Grade 3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title INR; Increase to Grade 4 Show more (12 of 39) denoms counts
group Id OG000
value 5
group Id OG001
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 received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
id OG000
title 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes
description Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
id OG001
title 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
param Type COUNT_OF_PARTICIPANTS
population Description All Treated Population
reporting Status POSTED
time Frame Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
title Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle