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NCT02034110 · OUTCOME

Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.

Analysis population: ITT/Evaluable population - Primary analysis cohort.

Groups in this outcome

Low Grade (WHO G1/G2) Glioma (LGG)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

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

Analysis denominator · Participants

GroupSource count
Low Grade (WHO G1/G2) Glioma (LGG)13

Reported measurements

Investigator assessment
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)NANot reported32.1NANot estimable due to insufficient events observed
Independent radiology review
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade (WHO G1/G2) Glioma (LGG)40.1Not reported20.3143.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to insufficient events observed
        group Id
        OG000
        lower Limit
        32.1
        upper Limit
        NA
        value
        NA
    title
    Investigator assessment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.3
        upper Limit
        143.7
        value
        40.1
    title
    Independent radiology review
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG000
    title
    Low Grade (WHO G1/G2) Glioma (LGG)
param Type
MEDIAN
population Description
ITT/Evaluable population - Primary analysis cohort.
reporting Status
POSTED
time Frame
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
type
SECONDARY
unit Of Measure
Weeks

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

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