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NCT03962543 · OUTCOME

Change From Baseline in Range of Motion of PN-Associated Functional Impairment 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
degrees
Interval / dispersion
Standard Deviation
Time frame
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

What was measured

If motor dysfunction or weakness is evident, range of motion of the affected areas and/or joints will be measured by a goniometer.

Analysis population: The Full Analysis Set patients who are 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)15
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)23

Reported measurements

Source class 1
Values in degrees · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)-6.182.06Not reportedNot reportedNot reported
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)17.751.28Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.06
        value
        -6.1
      2. group Id
        OG001
        spread
        51.28
        value
        17.7
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      23
    units
    Participants
description
If motor dysfunction or weakness is evident, range of motion of the affected areas and/or joints will be measured by a goniometer.
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 who are 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 Range of Motion of PN-Associated Functional Impairment at Cycle 13.
type
OTHER_PRE_SPECIFIED
unit Of Measure
degrees

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

Preserved source evidence · Not medical advice