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NCT03962543 · OUTCOME

Acceptability of the Dispersible Tablet Formulation as Measured by the Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ)

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
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Completed only once through study completion

What was measured

The Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ) uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Participants ≥ 8 years of age complete a 12-item self-report; adult parents/caregivers responsible for oversight of study drug administration for participants ages 6 months to 17 years complete a 19-item caregiver report. Each questionnaire is provided with a "past 7 days" recall with all items using a 5-point Numerical Rate Scale (1 to 5) with higher item-scores reflecting greater oral treatment acceptability. The overall P-OMAQ-P (pediatric self-report) and P-OMAQ-C (adult caregiver) scores for a participant in the study will be taken as the mean of all answered questions on the respective questionnaire.

Analysis population: The Full Analysis Set eligible for the instrument at baseline

Groups in this outcome

Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)

Patients aged 8 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

Adult Caregiver Mirdametinib (PD-0325901)

The adult caregiver of Pediatric patients aged 8 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

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)13
Adult Caregiver Mirdametinib (PD-0325901)17

Reported measurements

P-OMAQ-P
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)4.30.87Not reportedNot reportedNot reported
Adult Caregiver Mirdametinib (PD-0325901)NANANot reportedNot reportedNot eligible for this scale.
P-OMAQ-C
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)NANANot reportedNot reportedNot eligible for this scale.
Adult Caregiver Mirdametinib (PD-0325901)4.560.586Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.87
        value
        4.3
      2. comment
        Not eligible for this scale.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    P-OMAQ-P
  2. categories
    1. measurements
      1. comment
        Not eligible for this scale.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        0.586
        value
        4.56
    title
    P-OMAQ-C
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      17
    units
    Participants
description
The Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ) uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Participants ≥ 8 years of age complete a 12-item self-report; adult parents/caregivers responsible for oversight of study drug administration for participants ages 6 months to 17 years complete a 19-item caregiver report. Each questionnaire is provided with a "past 7 days" recall with all items using a 5-point Numerical Rate Scale (1 to 5) with higher item-scores reflecting greater oral treatment acceptability. The overall P-OMAQ-P (pediatric self-report) and P-OMAQ-C (adult caregiver) scores for a participant in the study will be taken as the mean of all answered questions on the respective questionnaire.
dispersion Type
Standard Deviation
groups
  1. description
    Patients aged 8 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
    The adult caregiver of Pediatric patients aged 8 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
    OG001
    title
    Adult Caregiver Mirdametinib (PD-0325901)
param Type
MEAN
population Description
The Full Analysis Set eligible for the instrument at baseline
reporting Status
POSTED
time Frame
Completed only once through study completion
title
Acceptability of the Dispersible Tablet Formulation as Measured by the Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ)
type
OTHER_PRE_SPECIFIED
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice