NCT03962543 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants

groups

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
BG000
title
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
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
BG001
title
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
4.50
value
10.1
group Id
BG001
spread
13.17
value
35.0
group Id
BG002
spread
15.94
value
22.8
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
37
group Id
BG002
value
67
title
Female
measurements
group Id
BG000
value
26
group Id
BG001
value
21
group Id
BG002
value
47
title
Male
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
1
group Id
BG002
value
9
title
Hispanic or Latino
measurements
group Id
BG000
value
44
group Id
BG001
value
52
group Id
BG002
value
96
title
Not Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
5
group Id
BG002
value
16
title
Black or African American
measurements
group Id
BG000
value
37
group Id
BG001
value
49
group Id
BG002
value
86
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
9.33
value
94.5
group Id
BG001
spread
7.73
value
87.1
group Id
BG002
spread
9.29
value
90.7
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
description
Karnofsky (\>= 16 years of age) and Lansky (\< 16 years of age) performance scores are intended to be multiples of 10 ranging from 0 to 100 with larger scores indicating better outcomes.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Karnofsky/Lansky Score
unit Of Measure
units on a scale
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
29
group Id
BG002
value
44
title
Yes
measurements
group Id
BG000
value
15
group Id
BG001
value
8
group Id
BG002
value
23
title
No
denoms
counts
group Id
BG000
value
30
group Id
BG001
value
37
group Id
BG002
value
67
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Based on the number of female patients in the Full Analysis Set
title
Childbearing Potential at Screening
unit Of Measure
Participants

population Description

Full Analysis Set (Received At Least One Dose of Mirdametinib)

Complete source fields

denoms

counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants

groups

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
BG000
title
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
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
BG001
title
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
4.50
value
10.1
group Id
BG001
spread
13.17
value
35.0
group Id
BG002
spread
15.94
value
22.8
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
37
group Id
BG002
value
67
title
Female
measurements
group Id
BG000
value
26
group Id
BG001
value
21
group Id
BG002
value
47
title
Male
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
1
group Id
BG002
value
9
title
Hispanic or Latino
measurements
group Id
BG000
value
44
group Id
BG001
value
52
group Id
BG002
value
96
title
Not Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
5
group Id
BG002
value
16
title
Black or African American
measurements
group Id
BG000
value
37
group Id
BG001
value
49
group Id
BG002
value
86
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
9.33
value
94.5
group Id
BG001
spread
7.73
value
87.1
group Id
BG002
spread
9.29
value
90.7
denoms
counts
group Id
BG000
value
56
group Id
BG001
value
58
group Id
BG002
value
114
units
Participants
description
Karnofsky (\>= 16 years of age) and Lansky (\< 16 years of age) performance scores are intended to be multiples of 10 ranging from 0 to 100 with larger scores indicating better outcomes.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Karnofsky/Lansky Score
unit Of Measure
units on a scale
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
29
group Id
BG002
value
44
title
Yes
measurements
group Id
BG000
value
15
group Id
BG001
value
8
group Id
BG002
value
23
title
No
denoms
counts
group Id
BG000
value
30
group Id
BG001
value
37
group Id
BG002
value
67
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Based on the number of female patients in the Full Analysis Set
title
Childbearing Potential at Screening
unit Of Measure
Participants

population Description

Full Analysis Set (Received At Least One Dose of Mirdametinib)

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

Preserved source evidence · Not medical advice