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NCT01667419 · OUTCOME

Overall Survival (OS)

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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 randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)

What was measured

OS is defined as the time from randomization until the date of death from any cause.

Analysis population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.

Groups in this outcome

Cohort 1 Vemurafenib

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 1 Placebo

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Vemurafenib

Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Placebo

Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

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

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib157
Cohort 1 Placebo157
Cohort 2 Vemurafenib93
Cohort 2 Placebo91

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 VemurafenibNANot reported60NANot estimable due to low number of events.
Cohort 1 PlaceboNANot reportedNANANot estimable due to low number of events.
Cohort 2 Vemurafenib59.9Not reported54.659.9Not reported
Cohort 2 PlaceboNANot reported52.6NANot estimable due to low number of events.

Source statistical analyses

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

  1. ci Lower Limit
    0.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    .94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0274
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.66
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8597
    param Type
    Hazard Ratio (HR)
    param Value
    .95
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    .94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0274
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.66
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8597
    param Type
    Hazard Ratio (HR)
    param Value
    .95
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to low number of events.
        group Id
        OG000
        lower Limit
        60
        upper Limit
        NA
        value
        NA
      2. comment
        Not estimable due to low number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        54.6
        upper Limit
        59.9
        value
        59.9
      4. comment
        Not estimable due to low number of events.
        group Id
        OG003
        lower Limit
        52.6
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      157
    3. group Id
      OG002
      value
      93
    4. group Id
      OG003
      value
      91
    units
    Participants
description
OS is defined as the time from randomization until the date of death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG000
    title
    Cohort 1 Vemurafenib
  2. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG001
    title
    Cohort 1 Placebo
  3. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG002
    title
    Cohort 2 Vemurafenib
  4. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG003
    title
    Cohort 2 Placebo
param Type
MEDIAN
population Description
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
reporting Status
POSTED
time Frame
From randomization until the date of death from any cause (up until 13-July-2018, 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