Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01909453 · OUTCOME

Part 2: Number of Participants With Worst Post-baseline LVEF Values by MUGA Scans or Transthoracic ECHO, by CTCAE Grade

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

LVEF values were graded as Grade 0: non missing value below Grade 2; Grade 2: LVEF between 40% and 50% or absolute reduction from baseline \>=10% and \< 20%; Grade 3: LVEF between 20% and 39% or absolute reduction from baseline \>=20%; Grade 4: LVEF lower than 20%. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Missing data were due to participants who died or withdrew consent prior to the first scheduled evaluation or missed evaluations as protocol deviations.

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.

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

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)257
Part 2: LGX818 300 mg84
Part 1 + Part 2: LGX818 300 mg276

Reported measurements

Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)172Not reportedNot reportedNot reportedNot reported
Part 2: LGX818 300 mg70Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg229Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)77Not reportedNot reportedNot reportedNot reported
Part 2: LGX818 300 mg9Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg27Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)6Not reportedNot reportedNot reportedNot reported
Part 2: LGX818 300 mg0Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg5Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)0Not reportedNot reportedNot reportedNot reported
Part 2: LGX818 300 mg0Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg0Not reportedNot reportedNot reportedNot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)2Not reportedNot reportedNot reportedNot reported
Part 2: LGX818 300 mg5Not reportedNot reportedNot reportedNot reported
Part 1 + Part 2: LGX818 300 mg15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        172
      2. group Id
        OG001
        value
        70
      3. group Id
        OG002
        value
        229
    title
    Grade 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        27
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        15
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      257
    2. group Id
      OG001
      value
      84
    3. group Id
      OG002
      value
      276
    units
    Participants
description
LVEF values were graded as Grade 0: non missing value below Grade 2; Grade 2: LVEF between 40% and 50% or absolute reduction from baseline \>=10% and \< 20%; Grade 3: LVEF between 20% and 39% or absolute reduction from baseline \>=20%; Grade 4: LVEF lower than 20%. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Missing data were due to participants who died or withdrew consent prior to the first scheduled evaluation or missed evaluations as protocol deviations.
groups
  1. 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)
  2. 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
  3. 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.
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 Worst Post-baseline LVEF Values by MUGA Scans or Transthoracic ECHO, by CTCAE Grade
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice