Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      192

   2. group Id

      BG001

      value

      194

   3. group Id

      BG002

      value

      191

   4. group Id

      BG003

      value

      258

   5. group Id

      BG004

      value

      86

   6. group Id

      BG005

      value

      921

   units

   Participants

groups

1. 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

   BG000

   title

   Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)

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

   BG001

   title

   Part 1: LGX818 300 mg

3. 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

   BG002

   title

   Part 1: Vemurafenib 960 mg BID

4. 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

   BG003

   title

   Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

5. 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

   BG004

   title

   Part 2: LGX818 300 mg

6. description

   Total of all reporting groups

   id

   BG005

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         4. group Id

            BG003

            value

            0

         5. group Id

            BG004

            value

            0

         6. group Id

            BG005

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            132

         2. group Id

            BG001

            value

            154

         3. group Id

            BG002

            value

            140

         4. group Id

            BG003

            value

            175

         5. group Id

            BG004

            value

            60

         6. group Id

            BG005

            value

            661

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            60

         2. group Id

            BG001

            value

            40

         3. group Id

            BG002

            value

            51

         4. group Id

            BG003

            value

            83

         5. group Id

            BG004

            value

            26

         6. group Id

            BG005

            value

            260

         title

         >=65 years

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            77

         2. group Id

            BG001

            value

            86

         3. group Id

            BG002

            value

            80

         4. group Id

            BG003

            value

            107

         5. group Id

            BG004

            value

            42

         6. group Id

            BG005

            value

            392

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            115

         2. group Id

            BG001

            value

            108

         3. group Id

            BG002

            value

            111

         4. group Id

            BG003

            value

            151

         5. group Id

            BG004

            value

            44

         6. group Id

            BG005

            value

            529

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

population Description

Full analysis set (FAS) included all randomized participants.

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

Preserved source evidence · Not medical advice