Skip to content

TriangleGet started

← Full study record

NCT01909453 · OUTCOME

Part 2: 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 after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 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 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 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.

Part 2: 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 + Part 2: LGX818 300 mg

Participants of Part 1 and 2 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, and 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 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Reported measurements

Hemoglobin (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	23	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	6	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	18	Not reported	Not reported	Not reported	Not reported

Hemoglobin (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	2	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported

Prothrombin international normalized ratio increased

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	246
Part 2: LGX818 300 mg	80
Part 1 + Part 2: LGX818 300 mg	268

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	5	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported

Lymphocytes (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	44	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	13	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	34	Not reported	Not reported	Not reported	Not reported

Lymphocytes (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	13	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	14	Not reported	Not reported	Not reported	Not reported

Neutrophils (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	36	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	6	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	13	Not reported	Not reported	Not reported	Not reported

Platelets (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	256
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	3	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	5	Not reported	Not reported	Not reported	Not reported

Leukocytes (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	16	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	7	Not reported	Not reported	Not reported	Not reported

Albumin (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	9	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	4	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	9	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	12	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	2	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	5	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	20	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	9	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	17	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	5	Not reported	Not reported	Not reported	Not reported

Bilirubin (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	4	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported

Creatine kinase (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	274

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	58	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported

Corrected Calcium (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	5	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	2	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	5	Not reported	Not reported	Not reported	Not reported

Corrected Calcium (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	4	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported

Creatinine (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	65	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	14	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	31	Not reported	Not reported	Not reported	Not reported

Gamma-glutamyl transferase (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	45	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	7	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	37	Not reported	Not reported	Not reported	Not reported

Fasting Glucose (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	207
Part 2: LGX818 300 mg	67
Part 1 + Part 2: LGX818 300 mg	216

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	5	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	4	Not reported	Not reported	Not reported	Not reported

Fasting Glucose (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	207
Part 2: LGX818 300 mg	67
Part 1 + Part 2: LGX818 300 mg	216

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	29	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	4	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	18	Not reported	Not reported	Not reported	Not reported

Magnesium (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	274

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	0	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported

Magnesium (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	274

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	3	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported

Phosphate (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	274

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	35	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	10	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	35	Not reported	Not reported	Not reported	Not reported

Potassium (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	2	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	2	Not reported	Not reported	Not reported	Not reported

Potassium (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	13	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	9	Not reported	Not reported	Not reported	Not reported

Sodium (hypo)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	6	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	2	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	3	Not reported	Not reported	Not reported	Not reported

Sodium (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	276

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	3	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported

Activated Partial Thromboplastin Time (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	246
Part 2: LGX818 300 mg	80
Part 1 + Part 2: LGX818 300 mg	268

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	1	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	0	Not reported	Not reported	Not reported	Not reported

Urate (hyper)

Analysis denominator · Participants

Group	Source count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	257
Part 2: LGX818 300 mg	84
Part 1 + Part 2: LGX818 300 mg	275

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)	3	Not reported	Not reported	Not reported	Not reported
Part 2: LGX818 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part 1 + Part 2: LGX818 300 mg	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
23
group Id
OG001
value
6
group Id
OG002
value
18
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Hemoglobin (hypo)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Hemoglobin (hyper)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
246
group Id
OG001
value
80
group Id
OG002
value
268
units
Participants
title
Prothrombin international normalized ratio increased
categories
measurements
group Id
OG000
value
44
group Id
OG001
value
13
group Id
OG002
value
34
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
275
units
Participants
title
Lymphocytes (hypo)
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
3
group Id
OG002
value
14
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
275
units
Participants
title
Lymphocytes (hyper)
categories
measurements
group Id
OG000
value
36
group Id
OG001
value
6
group Id
OG002
value
13
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Neutrophils (hypo)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
256
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Platelets (hypo)
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
3
group Id
OG002
value
7
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Leukocytes (hypo)
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
4
group Id
OG002
value
9
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Albumin (hypo)
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
2
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Alkaline phosphatase (hyper)
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
1
group Id
OG002
value
9
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Alanine aminotransferase (hyper)
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
1
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
units
Participants
title
Aspartate aminotransferase (hyper)

denoms

counts
group Id
OG000
value
257
group Id
OG001
value
84
group Id
OG002
value
276
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 300 mg of LGX818 orally once daily along with 45 mg of MEK162 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
OG000
title
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
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 2: LGX818 300 mg
description
Participants of Part 1 and 2 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, and study discontinuation, lost to follow-up or death.
id
OG002
title
Part 1 + Part 2: LGX818 300 mg

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 after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)

title

Part 2: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice