Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01584648 · OUTCOME

Overall Survival (OS)

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization until date of death due to any cause (up to approximately 6 years)

What was measured

OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.

Analysis population: Intent-to-Treat (ITT) Population was considered.

Groups in this outcome

Dabrafenib + Trametinib

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.

Dabrafenib + Placebo

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.

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 + Trametinib211
Dabrafenib + Placebo212

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dabrafenib + Trametinib25.8Not reported19.238.2Not reported
Dabrafenib + Placebo18.7Not reported15.223.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    Hazard ratios (HRs) were estimated using a Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    Hazard ratios (HRs) were estimated using a Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.2
        upper Limit
        38.2
        value
        25.8
      2. group Id
        OG001
        lower Limit
        15.2
        upper Limit
        23.1
        value
        18.7
denoms
  1. counts
    1. group Id
      OG000
      value
      211
    2. group Id
      OG001
      value
      212
    units
    Participants
description
OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Dabrafenib + Placebo
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Population was considered.
reporting Status
POSTED
time Frame
From the date of randomization until date of death due to any cause (up to approximately 6 years)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice