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NCT03973918 · OUTCOME

Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG · Source last updated 2024-10-31

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
up to 3 years

What was measured

time from first dose to 30 days post last dose

Groups in this outcome

Patients Treated With Encorafenib or Binimetinib in All Cohorts

Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both. Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors

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

Analysis denominator · Participants

GroupSource count
Patients Treated With Encorafenib or Binimetinib in All Cohorts5

Reported measurements

Dysphasia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
alanine aminotransferase increased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts60Not reportedNot reportedNot reportedNot reported
anemia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
blurred vision
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts40Not reportedNot reportedNot reportedNot reported
CK serum
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
CPK increased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts60Not reportedNot reportedNot reportedNot reported
dysuria
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
fatigue
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
fever
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
floaters
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
insomnia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
musculoskeletal, connective tissue disorder
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
myalgia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
pain
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
right ciliorecinal artery occlusion
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
rash acneiform
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
retinopathy
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts40Not reportedNot reportedNot reportedNot reported
urinary tract infection
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
vision decreased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
weight gain
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts20Not reportedNot reportedNot reportedNot reported
ASPARTATE AMINOTRANSFERASE INCREASED
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Treated With Encorafenib or Binimetinib in All Cohorts40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Dysphasia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        60
    title
    alanine aminotransferase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        40
    title
    blurred vision
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    CK serum
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        60
    title
    CPK increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    dysuria
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    fatigue
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    fever
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    floaters
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    insomnia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    musculoskeletal, connective tissue disorder
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
time from first dose to 30 days post last dose
groups
  1. description
    Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both. Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors
    id
    OG000
    title
    Patients Treated With Encorafenib or Binimetinib in All Cohorts
param Type
NUMBER
reporting Status
POSTED
time Frame
up to 3 years
title
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
type
SECONDARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice