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NCT01266967 · OUTCOME

Overall Survival of V600E Mutation-positive Participants

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08

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
Time from the first dose of study medication until death due to any cause (average of 35 weeks)

What was measured

Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.

Analysis population: V600E Population

Groups in this outcome

GSK2118436 150 mg: No Prior Local Therapy

Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

GSK2118436 150 mg: Prior Local Therapy

Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

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

Analysis denominator · Participants

GroupSource count
GSK2118436 150 mg: No Prior Local Therapy74
GSK2118436 150 mg: Prior Local Therapy65

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy6.8Not reported6.19.2Not reported
GSK2118436 150 mg: Prior Local Therapy7.6Not reported6.310.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        9.2
        value
        6.8
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        10.6
        value
        7.6
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG000
    title
    GSK2118436 150 mg: No Prior Local Therapy
  2. description
    Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG001
    title
    GSK2118436 150 mg: Prior Local Therapy
param Type
MEDIAN
population Description
V600E Population
reporting Status
POSTED
time Frame
Time from the first dose of study medication until death due to any cause (average of 35 weeks)
title
Overall Survival of V600E Mutation-positive Participants
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice