NCT01587703 · OUTCOME
Number of Participants With Maximum Urinalysis Change From Baseline-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), Weeks 5,9,17,25 and disc/prog What was measured Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Analysis population: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Groups in this outcome 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 Hyaline casts; Week5;n=1,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Hyaline casts; Week9;n=2,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Hyaline casts; Week17;n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Hyaline casts; Week25;n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Glucose; Week5;n=3,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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
Glucose; Week9;n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Glucose; Week17;n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Ketones; Week9;n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
pH;Week5;n=3,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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
pH;Week9;n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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 0 Not reported Not reported Not reported Not reported
pH;Week17;n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
pH;Week25;n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
pH;disc/prog;n=2,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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 1 Not reported Not reported Not reported Not reported
Protein; Week5; n=3,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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
Protein; Week9; n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Protein; Week17; n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Protein; Week25; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Erythrocytes; Week9; n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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 1 Not reported Not reported Not reported Not reported
Erythrocytes; Week17; n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Erythrocytes; Week25; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Erythrocytes; disc/prog; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Specific gravity; Week5; n=3,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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
Specific gravity; Week9; n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Specific gravity; Week17; n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Specific gravity; Week25; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Specific gravity; disc/prog; n=2,2 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2
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 1 Not reported Not reported Not reported Not reported
Leukocytes; Week5; n=3,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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
Leukocytes; Week9; n=4,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
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 1 Not reported Not reported Not reported Not reported
Leukocytes; Week17; n=2,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Leukocytes; Week25; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Leukocytes; disc/prog; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
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
Complete source fields classes categories measurements
group Id OG000
value 1
group Id OG001
value 1 denoms counts
group Id OG000
value 1
group Id OG001
value 1
units Participants
title Hyaline casts; Week5;n=1,1 categories measurements
group Id OG000
value 1
group Id OG001
value 0 denoms counts
group Id OG000
value 2
group Id OG001
value 1
units Participants
title Hyaline casts; Week9;n=2,1 denoms counts
group Id OG000
value 1
group Id OG001
value 0
units Participants
title Hyaline casts; Week17;n=1,0 denoms counts
group Id OG000
value 1
group Id OG001
value 0
units Participants
title Hyaline casts; Week25;n=1,0 categories measurements
group Id OG000
value 1
group Id OG001
value 1 denoms counts
group Id OG000
value 3
group Id OG001
value 2
units Participants
title Glucose; Week5;n=3,2 categories measurements
group Id OG000
value 1
group Id OG001
value 0 denoms counts
group Id OG000
value 4
group Id OG001
value 1
units Participants
title Glucose; Week9;n=4,1 denoms counts
group Id OG000
value 2
group Id OG001
value 0
units Participants
title Glucose; Week17;n=2,0 categories measurements
group Id OG000
value 1
group Id OG001
value 0 denoms counts
group Id OG000
value 4
group Id OG001
value 1
units Participants
title Ketones; Week9;n=4,1 categories measurements
group Id OG000
value 3
group Id OG001
value 1 denoms counts
group Id OG000
value 3
group Id OG001
value 2
units Participants
title pH;Week5;n=3,2 categories measurements
group Id OG000
value 3
group Id OG001
value 0 denoms counts
group Id OG000
value 4
group Id OG001
value 1
units Participants
title pH;Week9;n=4,1 denoms counts
group Id OG000
value 2
group Id OG001
value 0
units Participants
title pH;Week17;n=2,0 denoms counts
group Id OG000
value 1
group Id OG001
value 0
units Participants
title pH;Week25;n=1,0 Show more (12 of 31) denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
description Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. groups
description Participants 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. 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), Weeks 5,9,17,25 and disc/prog
title Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle