Part 1: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27
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 up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
What was measured
Laboratory parameters were graded using NCI-CTCAE v4.03 where, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to \>=grade 3. Only categories with non-zero values for any reporting arm are reported.
Analysis population: Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, 'Number analyzed' signifies number of participants evaluable for specified rows.
Groups in this outcome
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: LGX818 300 mg
Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: Vemurafenib 960 mg BID
Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
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 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Reported measurements
Hemoglobin (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
28
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
12
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
17
Not reported
Not reported
Not reported
Not reported
Hemoglobin (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
0
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
0
Not reported
Not reported
Not reported
Not reported
Prothrombin international normalized ratio (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
180
Part 1: LGX818 300 mg
188
Part 1: Vemurafenib 960 mg BID
181
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
0
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
2
Not reported
Not reported
Not reported
Not reported
Lymphocytes (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
30
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
21
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
42
Not reported
Not reported
Not reported
Not reported
Lymphocytes (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
15
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
11
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
6
Not reported
Not reported
Not reported
Not reported
Neutrophils (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
20
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
7
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
3
Not reported
Not reported
Not reported
Not reported
Platelets (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
3
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
4
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
1
Not reported
Not reported
Not reported
Not reported
Leukocytes (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
8
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
4
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
4
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
8
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
3
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
4
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
16
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
8
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
8
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
12
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
4
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
5
Not reported
Not reported
Not reported
Not reported
Bilirubin (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
1
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
0
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
15
Not reported
Not reported
Not reported
Not reported
Creatine kinase (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
191
Part 1: LGX818 300 mg
190
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
43
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
2
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
2
Not reported
Not reported
Not reported
Not reported
Corrected Calcium (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
3
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
3
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
3
Not reported
Not reported
Not reported
Not reported
Corrected Calcium (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
1
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
2
Not reported
Not reported
Not reported
Not reported
Creatinine (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
48
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
17
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
51
Not reported
Not reported
Not reported
Not reported
Gamma-glutamyl transferase (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
45
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
30
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
15
Not reported
Not reported
Not reported
Not reported
Fasting Glucose (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
155
Part 1: LGX818 300 mg
149
Part 1: Vemurafenib 960 mg BID
125
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
2
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
4
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
3
Not reported
Not reported
Not reported
Not reported
Fasting Glucose (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
155
Part 1: LGX818 300 mg
149
Part 1: Vemurafenib 960 mg BID
125
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
26
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
14
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
11
Not reported
Not reported
Not reported
Not reported
Magnesium (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
190
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
0
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
0
Not reported
Not reported
Not reported
Not reported
Magnesium (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
190
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
2
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
3
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
1
Not reported
Not reported
Not reported
Not reported
Phosphate (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
190
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
30
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
25
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
35
Not reported
Not reported
Not reported
Not reported
Potassium (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
2
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
3
Not reported
Not reported
Not reported
Not reported
Potassium (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
12
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
6
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
6
Not reported
Not reported
Not reported
Not reported
Sodium (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
10
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
1
Not reported
Not reported
Not reported
Not reported
Sodium (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
1
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
1
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
0
Not reported
Not reported
Not reported
Not reported
Albumin (hypo)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
192
Part 1: LGX818 300 mg
192
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
5
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
5
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
2
Not reported
Not reported
Not reported
Not reported
Urate (hyper)
Analysis denominator · Participants
Group
Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
191
Part 1: LGX818 300 mg
191
Part 1: Vemurafenib 960 mg BID
186
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
2
Not reported
Not reported
Not reported
Not reported
Part 1: LGX818 300 mg
3
Not reported
Not reported
Not reported
Not reported
Part 1: Vemurafenib 960 mg BID
9
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
12
group Id
OG002
value
17
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Hemoglobin (hypo)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Hemoglobin (hyper)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
188
group Id
OG002
value
181
units
Participants
title
Prothrombin international normalized ratio (hyper)
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
21
group Id
OG002
value
42
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
191
group Id
OG002
value
186
units
Participants
title
Lymphocytes (hypo)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
11
group Id
OG002
value
6
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
191
group Id
OG002
value
186
units
Participants
title
Lymphocytes (hyper)
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
7
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Neutrophils (hypo)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Platelets (hypo)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
4
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Leukocytes (hypo)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
3
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Alkaline Phosphatase (hyper)
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
8
group Id
OG002
value
8
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Alanine Aminotransferase (hyper)
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
4
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Aspartate Aminotransferase (hyper)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
15
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
title
Bilirubin (hyper)
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
192
group Id
OG002
value
186
units
Participants
description
Laboratory parameters were graded using NCI-CTCAE v4.03 where, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to \>=grade 3. Only categories with non-zero values for any reporting arm are reported.
groups
description
Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
id
OG000
title
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
description
Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
id
OG001
title
Part 1: LGX818 300 mg
description
Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
id
OG002
title
Part 1: Vemurafenib 960 mg BID
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, 'Number analyzed' signifies number of participants evaluable for specified rows.
reporting Status
POSTED
time Frame
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
title
Part 1: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03
Triangle