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NCT01597908 · OUTCOME

Overall Survival (OS)

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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

Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.

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

Groups in this outcome

Dabrafenib Plus Trametinib

Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.

Vemurafenib

Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.

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 Plus Trametinib352
Vemurafenib352

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dabrafenib Plus Trametinib26.0Not reported22.133.8Not reported
Vemurafenib17.8Not reported15.620.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    Hazard ratios are 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
    0.70
Complete source fields
analyses
  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    Hazard ratios are 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
    0.70
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.1
        upper Limit
        33.8
        value
        26.0
      2. group Id
        OG001
        lower Limit
        15.6
        upper Limit
        20.7
        value
        17.8
denoms
  1. counts
    1. group Id
      OG000
      value
      352
    2. group Id
      OG001
      value
      352
    units
    Participants
description
Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    Vemurafenib
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Population.
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
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Independent clinical review pending · Not medical advice