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NCT02039947 · OUTCOME

Duration of Intracranial, Extracranial and Overall Response for Each Cohort

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 first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression

What was measured

Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. 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

Duration of intracranial
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A6.5Not reported4.98.6Not reported
Cohort B7.3Not reported3.612.6Not reported
Cohort C8.3Not reported1.315.0Not reported
Cohort D4.5Not reported2.85.9Not reported
Duration of extracranial
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A10.2Not reported5.8NAUpper Limit not reachable.
Cohort BNANot reportedNANALower and upper Limit not reachable.
Cohort C4.9Not reported3.022.4Not reported
Cohort D5.9Not reported1.8NAUpper Limit not reachable.
Duration of Overall Response
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A6.2Not reported4.98.3Not reported
Cohort B12.5Not reported5.3NAUpper Limit not reachable.
Cohort C6.6Not reported1.316.3Not reported
Cohort D4.5Not reported2.811.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.9
        upper Limit
        8.6
        value
        6.5
      2. group Id
        OG001
        lower Limit
        3.6
        upper Limit
        12.6
        value
        7.3
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        15.0
        value
        8.3
      4. group Id
        OG003
        lower Limit
        2.8
        upper Limit
        5.9
        value
        4.5
    title
    Duration of intracranial
  2. categories
    1. measurements
      1. comment
        Upper Limit not reachable.
        group Id
        OG000
        lower Limit
        5.8
        upper Limit
        NA
        value
        10.2
      2. comment
        Lower and upper Limit not reachable.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        3.0
        upper Limit
        22.4
        value
        4.9
      4. comment
        Upper Limit not reachable.
        group Id
        OG003
        lower Limit
        1.8
        upper Limit
        NA
        value
        5.9
    title
    Duration of extracranial
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.9
        upper Limit
        8.3
        value
        6.2
      2. comment
        Upper Limit not reachable.
        group Id
        OG001
        lower Limit
        5.3
        upper Limit
        NA
        value
        12.5
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        16.3
        value
        6.6
      4. group Id
        OG003
        lower Limit
        2.8
        upper Limit
        11.2
        value
        4.5
    title
    Duration of Overall Response
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
Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. 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 first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression
title
Duration of Intracranial, Extracranial and Overall Response for Each Cohort
type
SECONDARY
unit Of Measure
Month

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

Preserved source evidence · Not medical advice