Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From Screening until the conclusion of the study (up to 103 weeks)
What was measured
Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) \>=5.
Analysis population: ATS Population
Groups in this outcome
GSK2118436 150 mg: No Prior Local Therapy
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
GSK2118436 150 mg: Prior Local Therapy
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
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
GSK2118436 150 mg: No Prior Local Therapy
89
GSK2118436 150 mg: Prior Local Therapy
83
Reported measurements
Possible HYs Law, >3x ULN ALT, >=2x ULN BIL
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
Possible HYs Law, >3x ULN ALT, >1.5x ULN INR
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
Hepato-cellular injury
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
2
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
Bilirubin elevations, >=2x ULN BIL
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
Bilirubin elevations, >=2x ULN BIL and <2x ULN BIL
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
ALT or AST elevations, >3x ULN ALT or AST
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
2
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
4
Not reported
Not reported
Not reported
Not reported
ALT or AST elevations, >5x ULN ALT or AST
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
ALT or AST elevations, >8x ULN ALT or AST
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
ALT or AST elevations, >20x ULN ALT or AST
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
ALT elevations, >3x ULN ALT
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
2
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
4
Not reported
Not reported
Not reported
Not reported
ALT elevations, >5x ULN ALT
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
ALT elevations, >8x ULN ALT
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
1
Not reported
Not reported
Not reported
Not reported
ALT elevations, >20x ULN ALT
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
0
Not reported
Not reported
Not reported
Not reported
ALT elevations, >3x ULN ALT, <=3x ULN ALT Baseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
2
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
4
Not reported
Not reported
Not reported
Not reported
ALP elevations, >=3x ULN ALP
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
5
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
2
Not reported
Not reported
Not reported
Not reported
ALP elevations, >=3x ULN ALP and <3x ULN ALP
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg: No Prior Local Therapy
4
Not reported
Not reported
Not reported
Not reported
GSK2118436 150 mg: Prior Local Therapy
2
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
Possible HYs Law, >3x ULN ALT, >=2x ULN BIL
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Possible HYs Law, >3x ULN ALT, >1.5x ULN INR
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Hepato-cellular injury
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Bilirubin elevations, >=2x ULN BIL
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Bilirubin elevations, >=2x ULN BIL and <2x ULN BIL
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
title
ALT or AST elevations, >3x ULN ALT or AST
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
ALT or AST elevations, >5x ULN ALT or AST
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
ALT or AST elevations, >8x ULN ALT or AST
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
ALT or AST elevations, >20x ULN ALT or AST
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
title
ALT elevations, >3x ULN ALT
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
ALT elevations, >5x ULN ALT
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
ALT elevations, >8x ULN ALT
denoms
counts
group Id
OG000
value
89
group Id
OG001
value
83
units
Participants
description
Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) \>=5.
groups
description
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
id
OG000
title
GSK2118436 150 mg: No Prior Local Therapy
description
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
id
OG001
title
GSK2118436 150 mg: Prior Local Therapy
param Type
NUMBER
population Description
ATS Population
reporting Status
POSTED
time Frame
From Screening until the conclusion of the study (up to 103 weeks)
title
Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities
Triangle