Baseline characteristics

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma · Source last updated 2021-02-17

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

      211

   2. group Id

      BG001

      value

      212

   3. group Id

      BG002

      value

      423

   units

   Participants

groups

1. description

   Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.

   id

   BG000

   title

   Dabrafenib + Trametinib

2. description

   Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

   id

   BG001

   title

   Dabrafenib + Placebo

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            13.33

            value

            55.1

         2. group Id

            BG001

            spread

            13.75

            value

            55.3

         3. group Id

            BG002

            spread

            13.52

            value

            55.2

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   Years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            100

         2. group Id

            BG001

            value

            98

         3. group Id

            BG002

            value

            198

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            111

         2. group Id

            BG001

            value

            114

         3. group Id

            BG002

            value

            225

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      African American/African Heritage

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            211

         2. group Id

            BG001

            value

            211

         3. group Id

            BG002

            value

            422

      title

      White - White/Caucasian/European Heritage

   param Type

   NUMBER

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

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

Preserved source evidence · Not medical advice