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NCT01072175 · OUTCOME

Part C (Randomized): Overall Survival (OS)

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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 7 years)

What was measured

OS is defined as the interval of time between the date of randomization until 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. When calculating overall survival, deaths following crossover were included.

Analysis population: ITT Population

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Dabrafenib 150 mg + Trametinib 1 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.

Part C: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.

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

Analysis denominator · Participants

GroupSource count
Part C: Dabrafenib 150 mg54
Part C: Dabrafenib 150 mg + Trametinib 1 mg54
Part C: Dabrafenib 150 mg + Trametinib 2 mg54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg20.2Not reported14.027.1Not reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg18.7Not reported13.735.3Not reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg25.0Not reported17.536.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.0
        upper Limit
        27.1
        value
        20.2
      2. group Id
        OG001
        lower Limit
        13.7
        upper Limit
        35.3
        value
        18.7
      3. group Id
        OG002
        lower Limit
        17.5
        upper Limit
        36.5
        value
        25.0
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      54
    units
    Participants
description
OS is defined as the interval of time between the date of randomization until 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. When calculating overall survival, deaths following crossover were included.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    OG001
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
From the date of randomization until date of death due to any cause (up to approximately 7 years)
title
Part C (Randomized): Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

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