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NCT02684058 · OUTCOME

HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13

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
Up to 5.1 years

What was measured

Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.

Analysis population: All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.

Groups in this outcome

HGG Cohort: Dabrafenib and Trametinib

Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)

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

Analysis denominator · Participants

GroupSource count
HGG Cohort: Dabrafenib and Trametinib41

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HGG Cohort: Dabrafenib and TrametinibNANot reported19.8NANot estimable (NA) due to the insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable (NA) due to the insufficient number of participants with events
        group Id
        OG000
        lower Limit
        19.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
    id
    OG000
    title
    HGG Cohort: Dabrafenib and Trametinib
param Type
MEDIAN
population Description
All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to 5.1 years
title
HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice