Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters
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
Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.
Analysis population: ATS Population. Only those participants with data available for the indicated parameters were analyzed.
Groups in this outcome
GSK2118436 150 mg
Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
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
165
Reported measurements
Glucose (hyperglycemia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
71
Not reported
Not reported
Not reported
Not reported
Glucose (hyperglycemia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
8
Not reported
Not reported
Not reported
Not reported
Glucose (hyperglycemia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
Glucose (hypoglycemia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
24
Not reported
Not reported
Not reported
Not reported
Glucose (hypoglycemia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Glucose (hypoglycemia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hypermagnesemia) AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
2
Not reported
Not reported
Not reported
Not reported
Magnesium (hypermagnesemia), Increase to G 3,n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hypermagnesemia), Increase to G 4,n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hypomagnesemia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hypomagnesemia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hypomagnesemia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Sodium (hypernatremia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
8
Not reported
Not reported
Not reported
Not reported
Sodium (hypernatremia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Sodium (hypernatremia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Sodium (hyponatremia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
21
Not reported
Not reported
Not reported
Not reported
Sodium (hyponatremia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
3
Not reported
Not reported
Not reported
Not reported
Sodium (hyponatremia), Increase to G. 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Phosphorus inorganic, AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
53
Not reported
Not reported
Not reported
Not reported
Phosphorus inorganic, Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
13
Not reported
Not reported
Not reported
Not reported
Phosphorus inorganic, Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Potassium (hyperkalemia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
8
Not reported
Not reported
Not reported
Not reported
Potassium (hyperkalemia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Potassium (hyperkalemia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Potassium (hypokalemia), AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
17
Not reported
Not reported
Not reported
Not reported
Potassium (hypokalemia), Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
4
Not reported
Not reported
Not reported
Not reported
Potassium (hypokalemia), Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
ALP, AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
41
Not reported
Not reported
Not reported
Not reported
ALP, Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
ALP, Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
AST, AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
26
Not reported
Not reported
Not reported
Not reported
AST, Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
AST, Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
ALT, AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
27
Not reported
Not reported
Not reported
Not reported
ALT, Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
2
Not reported
Not reported
Not reported
Not reported
ALT, Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Creatinine, AGI, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
10
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to G 3, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to G 4, n=165
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Total bilirubin, AGI, n=163
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
5
Not reported
Not reported
Not reported
Not reported
Total bilirubin, Increase to G 3 n=163
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Total bilirubin, Increase to G 4 n=163
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Albumin, AGI, n=27
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
9
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to G 3, n=27
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to G 4, n=27
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Amylase, AGI, n=16
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
3
Not reported
Not reported
Not reported
Not reported
Amylase, Increase to G 3, n=16
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
Amylase, Increase to G 4, n=16
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
Cholesterol, AGI, n=2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
Cholesterol, Increase to G 3, n=2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Cholesterol, Increase to G 4, n=2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Creatine kinase, AGI, n=6
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
Creatine kinase, Increase to G 3, n=6
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Creatine kinase, Increase to G 4, n=6
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
1
Not reported
Not reported
Not reported
Not reported
GGT, AGI, n=22
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
13
Not reported
Not reported
Not reported
Not reported
GGT, Increase to G 3, n=22
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
4
Not reported
Not reported
Not reported
Not reported
GGT, Increase to G 4, n=22
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Lipase, AGI, n=19
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
10
Not reported
Not reported
Not reported
Not reported
Lipase, Increase to G 3, n=19
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
4
Not reported
Not reported
Not reported
Not reported
Lipase, Increase to G 4, n=19
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
2
Not reported
Not reported
Not reported
Not reported
Blood pH, AGI, n=1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Blood pH, Increase to G 3, n=1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Blood pH, Increase to G 4, n=1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Triglycerides, AGI, n=5
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
3
Not reported
Not reported
Not reported
Not reported
Triglycerides, Increase to G 3, n=5
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Triglycerides, Increase to G 4, n=5
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
GSK2118436 150 mg
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
71
title
Glucose (hyperglycemia), AGI, n=165
categories
measurements
group Id
OG000
value
8
title
Glucose (hyperglycemia), Increase to G 3, n=165
categories
measurements
group Id
OG000
value
1
title
Glucose (hyperglycemia), Increase to G 4, n=165
categories
measurements
group Id
OG000
value
24
title
Glucose (hypoglycemia), AGI, n=165
categories
measurements
group Id
OG000
value
0
title
Glucose (hypoglycemia), Increase to G 3, n=165
categories
measurements
group Id
OG000
value
0
title
Glucose (hypoglycemia), Increase to G 4, n=165
categories
measurements
group Id
OG000
value
2
title
Magnesium (hypermagnesemia) AGI, n=165
categories
measurements
group Id
OG000
value
0
title
Magnesium (hypermagnesemia), Increase to G 3,n=165
categories
measurements
group Id
OG000
value
0
title
Magnesium (hypermagnesemia), Increase to G 4,n=165
categories
measurements
group Id
OG000
value
0
title
Magnesium (hypomagnesemia), AGI, n=165
categories
measurements
group Id
OG000
value
0
title
Magnesium (hypomagnesemia), Increase to G 3, n=165
categories
measurements
group Id
OG000
value
0
title
Magnesium (hypomagnesemia), Increase to G 4, n=165
denoms
counts
group Id
OG000
value
165
units
Participants
description
Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.
groups
description
Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
id
OG000
title
GSK2118436 150 mg
param Type
NUMBER
population Description
ATS Population. Only those participants with data available for the indicated parameters were analyzed.
reporting Status
POSTED
time Frame
From Screening until the conclusion of the study (up to 103 weeks)
title
Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters
Triangle