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NCT01682083 · OUTCOME

Percentage of Participants With Distant Metastasis-free Survival (DMFS) Events

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). · Source last updated 2026-04-21

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
Approximately 4 years

What was measured

Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.

Analysis population: Intent-to-Treat (ITT) Population

Groups in this outcome

Dabrafenib and Trametinib Combination Therapy

Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Dabrafenib and Trametinib Placebos

Subjects received matching placebos orally for 12 months

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dabrafenib and Trametinib Combination Therapy438
Dabrafenib and Trametinib Placebos432

Reported measurements

Source class 1

Relapsed (event)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy106Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos150Not reportedNot reportedNot reportedNot reported

Died (event)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy4Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos2Not reportedNot reportedNot reportedNot reported

Censored, follow-up ended at the time of Primary Completion Date

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy99Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos131Not reportedNot reportedNot reportedNot reported

Censored, follow-up ongoing at the time of Primary Completion Date

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy229Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos149Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        150
      title
      Relapsed (event)
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      title
      Died (event)
    3. measurements
      1. group Id
        OG000
        value
        99
      2. group Id
        OG001
        value
        131
      title
      Censored, follow-up ended at the time of Primary Completion Date
    4. measurements
      1. group Id
        OG000
        value
        229
      2. group Id
        OG001
        value
        149
      title
      Censored, follow-up ongoing at the time of Primary Completion Date
denoms
  1. counts
    1. group Id
      OG000
      value
      438
    2. group Id
      OG001
      value
      432
    units
    Participants
description
Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
groups
  1. description
    Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
    id
    OG000
    title
    Dabrafenib and Trametinib Combination Therapy
  2. description
    Subjects received matching placebos orally for 12 months
    id
    OG001
    title
    Dabrafenib and Trametinib Placebos
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-Treat (ITT) Population
reporting Status
POSTED
time Frame
Approximately 4 years
title
Percentage of Participants With Distant Metastasis-free Survival (DMFS) Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice