Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05
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
From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
What was measured
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Analysis population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
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 D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
15
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
15
Part D: Dabrafenib 75 mg + Trametinib 2 mg
41
Part D: Dabrafenib 150 mg + Trametinib 2 mg
39
Reported measurements
Direct Bilirubin
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Creatine Kinase MB mass
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Chloride
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
9
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
11
Part D: Dabrafenib 75 mg + Trametinib 2 mg
25
Part D: Dabrafenib 150 mg + Trametinib 2 mg
34
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
9
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
18
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
25
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
9
Not reported
Not reported
Not reported
Not reported
Carbon dioxide content/Bicarbonate
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
7
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
8
Part D: Dabrafenib 75 mg + Trametinib 2 mg
24
Part D: Dabrafenib 150 mg + Trametinib 2 mg
18
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
12
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
8
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
4
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
12
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
10
Not reported
Not reported
Not reported
Not reported
C-Reactive protein
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
3
Part D: Dabrafenib 150 mg + Trametinib 2 mg
3
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Creatinine Clearance
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
7
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
6
Part D: Dabrafenib 75 mg + Trametinib 2 mg
18
Part D: Dabrafenib 150 mg + Trametinib 2 mg
11
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
11
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
4
Not reported
Not reported
Not reported
Not reported
High Density Lipids cholesterol
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
9
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
10
Part D: Dabrafenib 75 mg + Trametinib 2 mg
21
Part D: Dabrafenib 150 mg + Trametinib 2 mg
24
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
4
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
20
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
20
Not reported
Not reported
Not reported
Not reported
Low Density Lipids cholesterol
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Total Protein
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
7
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
8
Part D: Dabrafenib 75 mg + Trametinib 2 mg
23
Part D: Dabrafenib 150 mg + Trametinib 2 mg
22
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
17
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
15
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
6
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
7
Not reported
Not reported
Not reported
Not reported
Troponin I
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Troponin T
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
0
Not reported
Not reported
Not reported
Not reported
Urea/BUN
Analysis denominator · Participants
Group
Source count
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
6
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
7
Part D: Dabrafenib 75 mg + Trametinib 2 mg
22
Part D: Dabrafenib 150 mg + Trametinib 2 mg
18
Decrease Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
10
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Increase to High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
4
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg
12
Not reported
Not reported
Not reported
Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg
13
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
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
units
Participants
title
Direct Bilirubin
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
Creatine Kinase MB mass
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
9
group Id
OG002
value
18
group Id
OG003
value
25
title
Decrease Low
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
7
group Id
OG003
value
9
title
Increase to High
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
11
group Id
OG002
value
25
group Id
OG003
value
34
units
Participants
title
Chloride
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
12
group Id
OG003
value
8
title
Decrease Low
measurements
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
12
group Id
OG003
value
10
title
Increase to High
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
24
group Id
OG003
value
18
units
Participants
title
Carbon dioxide content/Bicarbonate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
3
title
Increase to High
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
3
units
Participants
title
C-Reactive protein
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
7
group Id
OG003
value
7
title
Decrease Low
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
11
group Id
OG003
value
4
title
Increase to High
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
6
group Id
OG002
value
18
group Id
OG003
value
11
units
Participants
title
Creatinine Clearance
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
High Density Lipids cholesterol
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
4
title
Decrease Low
measurements
group Id
OG000
value
7
group Id
OG001
value
7
group Id
OG002
value
20
group Id
OG003
value
20
title
Increase to High
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
10
group Id
OG002
value
21
group Id
OG003
value
24
units
Participants
title
Lactate Dehydrogenase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
Low Density Lipids cholesterol
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
17
group Id
OG003
value
15
title
Decrease Low
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
6
group Id
OG003
value
7
title
Increase to High
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
23
group Id
OG003
value
22
units
Participants
title
Total Protein
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
Troponin I
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Decrease Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to High
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
units
Participants
title
Troponin T
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
15
group Id
OG002
value
41
group Id
OG003
value
39
units
Participants
description
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
groups
description
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
id
OG000
title
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
description
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
id
OG001
title
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
description
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
id
OG002
title
Part D: Dabrafenib 75 mg + Trametinib 2 mg
description
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
id
OG003
title
Part D: Dabrafenib 150 mg + Trametinib 2 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
reporting Status
POSTED
time Frame
From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
title
Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Triangle