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NCT03962543 · OUTCOME

Time to Response Defined as the Time Between First Dose and the First Date of Objective Response That is Subsequently Confirmed.

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
months
Interval / dispersion
Standard Deviation
Time frame
Up to 24 months

What was measured

Response will be determined by a blinded centralized review of volumetric MRI. Time to response is defined as the time in months from the start of treatment to the date of first response that was subsequently confirmed.

Analysis population: The Full Analysis Set patients who achieved confirmed objective response.

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)29
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)24

Reported measurements

Source class 1
Values in months · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)8.634.801Not reportedNot reportedNot reported
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)9.715.804Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.801
        value
        8.63
      2. group Id
        OG001
        spread
        5.804
        value
        9.71
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Response will be determined by a blinded centralized review of volumetric MRI. Time to response is defined as the time in months from the start of treatment to the date of first response that was subsequently confirmed.
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 achieved confirmed objective response.
reporting Status
POSTED
time Frame
Up to 24 months
title
Time to Response Defined as the Time Between First Dose and the First Date of Objective Response That is Subsequently Confirmed.
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice