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NCT01909453 · OUTCOME

Part 1: Number of Participants With Newly Occurring Notable Electrocardiogram (ECG) Values

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

Newly occurring notable ECG values were reported for QT (millisecond \[ms\]), QT corrected interval using Fridericia's correction (QTcF) (ms), QT corrected interval using Bazett's correction formula (QTcB) (ms) and heart rate (beats per minute). Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline. Criteria for newly occurring notable ECG values (QT, QTcF, QTcB) were New \> 450, New \>480, New \>500, Increase from baseline \>30, Increase from baseline \>60; heart rate: New \<60, New \>100.

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 "Overall Number of Participants analyzed" signifies number of participants evaluable for this outcome measure and '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)	187
Part 1: LGX818 300 mg	181
Part 1: Vemurafenib 960 mg BID	179

Reported measurements

QT: Increase >30 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	187
Part 1: LGX818 300 mg	181
Part 1: Vemurafenib 960 mg BID	179

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)	113	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	74	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	84	Not reported	Not reported	Not reported	Not reported

QT: Increase >60 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	187
Part 1: LGX818 300 mg	181
Part 1: Vemurafenib 960 mg BID	179

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)	32	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	24	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	28	Not reported	Not reported	Not reported	Not reported

QT: New >450 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	180
Part 1: LGX818 300 mg	170
Part 1: Vemurafenib 960 mg BID	173

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	21	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	22	Not reported	Not reported	Not reported	Not reported

QT: New >480 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	187
Part 1: LGX818 300 mg	177
Part 1: Vemurafenib 960 mg BID	178

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	7	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	4	Not reported	Not reported	Not reported	Not reported

QT: New >500 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	187
Part 1: LGX818 300 mg	179
Part 1: Vemurafenib 960 mg BID	179

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	2	Not reported	Not reported	Not reported	Not reported

QTcF: Increase >30 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	186
Part 1: LGX818 300 mg	180
Part 1: Vemurafenib 960 mg BID	179

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)	60	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	63	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	75	Not reported	Not reported	Not reported	Not reported

QTcF: Increase >60 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	186
Part 1: LGX818 300 mg	180
Part 1: Vemurafenib 960 mg BID	179

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	11	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	13	Not reported	Not reported	Not reported	Not reported

QTcF: New >450 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	178
Part 1: LGX818 300 mg	172
Part 1: Vemurafenib 960 mg BID	174

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)	33	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	42	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	42	Not reported	Not reported	Not reported	Not reported

QTcF: New >480 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	186
Part 1: LGX818 300 mg	178
Part 1: Vemurafenib 960 mg BID	179

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	10	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	6	Not reported	Not reported	Not reported	Not reported

QTcF: New >500 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	186
Part 1: LGX818 300 mg	179
Part 1: Vemurafenib 960 mg BID	179

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	7	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	3	Not reported	Not reported	Not reported	Not reported

QTcB: Increase >30 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	184
Part 1: LGX818 300 mg	180
Part 1: Vemurafenib 960 mg BID	177

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)	60	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	79	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	79	Not reported	Not reported	Not reported	Not reported

QTcB: Increase >60 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	184
Part 1: LGX818 300 mg	180
Part 1: Vemurafenib 960 mg BID	177

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	19	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	16	Not reported	Not reported	Not reported	Not reported

QTcB: New >450 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	155
Part 1: LGX818 300 mg	159
Part 1: Vemurafenib 960 mg BID	155

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)	54	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	78	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	66	Not reported	Not reported	Not reported	Not reported

QTcB: New >480 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	183
Part 1: LGX818 300 mg	175
Part 1: Vemurafenib 960 mg BID	176

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)	18	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	28	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	20	Not reported	Not reported	Not reported	Not reported

QTcB: New >500 ms

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	183
Part 1: LGX818 300 mg	180
Part 1: Vemurafenib 960 mg BID	177

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	13	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	10	Not reported	Not reported	Not reported	Not reported

Heart rate: New <60 bpm

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	163
Part 1: LGX818 300 mg	159
Part 1: Vemurafenib 960 mg BID	153

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)	62	Not reported	Not reported	Not reported	Not reported
Part 1: LGX818 300 mg	38	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	21	Not reported	Not reported	Not reported	Not reported

Heart rate: New >100 bpm

Analysis denominator · Participants

Group	Source count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)	182
Part 1: LGX818 300 mg	175
Part 1: Vemurafenib 960 mg BID	170

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	24	Not reported	Not reported	Not reported	Not reported
Part 1: Vemurafenib 960 mg BID	20	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
113
group Id
OG001
value
74
group Id
OG002
value
84
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
181
group Id
OG002
value
179
units
Participants
title
QT: Increase >30 ms
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
24
group Id
OG002
value
28
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
181
group Id
OG002
value
179
units
Participants
title
QT: Increase >60 ms
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
21
group Id
OG002
value
22
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
170
group Id
OG002
value
173
units
Participants
title
QT: New >450 ms
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
177
group Id
OG002
value
178
units
Participants
title
QT: New >480 ms
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
179
group Id
OG002
value
179
units
Participants
title
QT: New >500 ms
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
63
group Id
OG002
value
75
denoms
counts
group Id
OG000
value
186
group Id
OG001
value
180
group Id
OG002
value
179
units
Participants
title
QTcF: Increase >30 ms
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
11
group Id
OG002
value
13
denoms
counts
group Id
OG000
value
186
group Id
OG001
value
180
group Id
OG002
value
179
units
Participants
title
QTcF: Increase >60 ms
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
42
group Id
OG002
value
42
denoms
counts
group Id
OG000
value
178
group Id
OG001
value
172
group Id
OG002
value
174
units
Participants
title
QTcF: New >450 ms
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
10
group Id
OG002
value
6
denoms
counts
group Id
OG000
value
186
group Id
OG001
value
178
group Id
OG002
value
179
units
Participants
title
QTcF: New >480 ms
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
186
group Id
OG001
value
179
group Id
OG002
value
179
units
Participants
title
QTcF: New >500 ms
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
79
group Id
OG002
value
79
denoms
counts
group Id
OG000
value
184
group Id
OG001
value
180
group Id
OG002
value
177
units
Participants
title
QTcB: Increase >30 ms
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
19
group Id
OG002
value
16
denoms
counts
group Id
OG000
value
184
group Id
OG001
value
180
group Id
OG002
value
177
units
Participants
title
QTcB: Increase >60 ms

denoms

counts
group Id
OG000
value
187
group Id
OG001
value
181
group Id
OG002
value
179
units
Participants

description

Newly occurring notable ECG values were reported for QT (millisecond \[ms\]), QT corrected interval using Fridericia's correction (QTcF) (ms), QT corrected interval using Bazett's correction formula (QTcB) (ms) and heart rate (beats per minute). Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline. Criteria for newly occurring notable ECG values (QT, QTcF, QTcB) were New \> 450, New \>480, New \>500, Increase from baseline \>30, Increase from baseline \>60; heart rate: New \<60, New \>100.

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 "Overall Number of Participants analyzed" signifies number of participants evaluable for this outcome measure and '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 Newly Occurring Notable Electrocardiogram (ECG) Values

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice