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NCT02039947 · OUTCOME

Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain · Source last updated 2019-05-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Month
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose to the earliest date of disease progression or death

What was measured

PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D

Analysis population: All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population

Groups in this outcome

Cohort A

Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.

Cohort B

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

Cohort C

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

Cohort D

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

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 A76
Cohort B16
Cohort C16
Cohort D17

Reported measurements

Source class 1
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A5.7Not reported5.37.3Not reported
Cohort B7.2Not reported4.714.6Not reported
Cohort C3.7Not reported1.76.5Not reported
Cohort D5.5Not reported3.711.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        7.3
        value
        5.7
      2. group Id
        OG001
        lower Limit
        4.7
        upper Limit
        14.6
        value
        7.2
      3. group Id
        OG002
        lower Limit
        1.7
        upper Limit
        6.5
        value
        3.7
      4. group Id
        OG003
        lower Limit
        3.7
        upper Limit
        11.6
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      16
    4. group Id
      OG003
      value
      17
    units
    Participants
description
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    OG000
    title
    Cohort A
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG001
    title
    Cohort B
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG002
    title
    Cohort C
  4. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    OG003
    title
    Cohort D
param Type
MEDIAN
population Description
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
reporting Status
POSTED
time Frame
From the first dose to the earliest date of disease progression or death
title
Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment
type
SECONDARY
unit Of Measure
Month

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

Preserved source evidence · Not medical advice