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NCT03962543 · OUTCOME

Change From Baseline in Endurance at Cycle 13.

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
MEAN
Unit
meters
Interval / dispersion
Standard Deviation
Time frame
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

What was measured

If airway or lower extremity motor dysfunction is evident, endurance will be measured by completion of a 6-minute walking test.

Analysis population: The Full Analysis Set patients eligible for this instrument at baseline

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)11
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)16

Reported measurements

Source class 1
Values in meters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)-6.860.76Not reportedNot reportedNot reported
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)2.270.41Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.76
        value
        -6.8
      2. group Id
        OG001
        spread
        70.41
        value
        2.2
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      16
    units
    Participants
description
If airway or lower extremity motor dysfunction is evident, endurance will be measured by completion of a 6-minute walking test.
dispersion Type
Standard Deviation
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
MEAN
population Description
The Full Analysis Set patients eligible for this instrument at baseline
reporting Status
POSTED
time Frame
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
title
Change From Baseline in Endurance at Cycle 13.
type
OTHER_PRE_SPECIFIED
unit Of Measure
meters

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

Preserved source evidence · Not medical advice