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NCT03962543 · OUTCOME

Percentage of Patients With Treatment-Emergent Adverse Events.

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas · Source last updated 2026-07-10

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
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 year and 10 months and up to 3 years and 10 months.

What was measured

All adverse events were coded using MedDRA Version 24.0. Adverse events will be assessed according to toxicities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Analysis population: The Full Analysis Set includes patients who received at least one dose of Mirdametinib.

Groups in this outcome

Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)

Patients aged 2 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily

Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)

Patients aged 18 and above at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily

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

Analysis denominator · Participants

GroupSource count
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)56
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)58

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)100Not reportedNot reportedNot reportedNot reported
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      58
    units
    Participants
description
All adverse events were coded using MedDRA Version 24.0. Adverse events will be assessed according to toxicities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
groups
  1. description
    Patients aged 2 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
    id
    OG000
    title
    Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
  2. description
    Patients aged 18 and above at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
    id
    OG001
    title
    Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)
param Type
NUMBER
population Description
The Full Analysis Set includes patients who received at least one dose of Mirdametinib.
reporting Status
POSTED
time Frame
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 year and 10 months and up to 3 years and 10 months.
title
Percentage of Patients With Treatment-Emergent Adverse Events.
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice