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NCT03566199 · OUTCOME

Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events

MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma · Source last updated 2022-02-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
Not reported
Time frame
Up to 12 Months

What was measured

Adverse events and clinically significant laboratory abnormalities which meet Grade 3, 4, or 5 criteria according to Common Terminology Criteria for Adverse Events (CTCAE) classified by investigators and treating physicians as related to study treatment (probable, possible, and definite) will be summarized by maximum intensity/grade. Adverse events will be graded according to CTCAE version 4.0.

Analysis population: While individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease study

Groups in this outcome

Phase 1: Treatment (MTX110)

Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1: Treatment (MTX110)7

Reported measurements

Muscle weakness right-sided (Grade 3)
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Treatment (MTX110)0.142Not reportedNot reportedNot reportedNot reported
Stridor (Grade 3)
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Treatment (MTX110)0.142Not reportedNot reportedNot reportedNot reported
Vagus nerve disorder (Grade 3)
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Treatment (MTX110)0.142Not reportedNot reportedNot reportedNot reported
Gait disturbance (Grade 3)
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Treatment (MTX110)0.142Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased (Grade 3)
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Treatment (MTX110)0.142Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.142
    title
    Muscle weakness right-sided (Grade 3)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.142
    title
    Stridor (Grade 3)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.142
    title
    Vagus nerve disorder (Grade 3)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.142
    title
    Gait disturbance (Grade 3)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.142
    title
    Neutrophil count decreased (Grade 3)
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Adverse events and clinically significant laboratory abnormalities which meet Grade 3, 4, or 5 criteria according to Common Terminology Criteria for Adverse Events (CTCAE) classified by investigators and treating physicians as related to study treatment (probable, possible, and definite) will be summarized by maximum intensity/grade. Adverse events will be graded according to CTCAE version 4.0.
groups
  1. description
    Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED
    id
    OG000
    title
    Phase 1: Treatment (MTX110)
param Type
NUMBER
population Description
While individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease study
reporting Status
POSTED
time Frame
Up to 12 Months
title
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events
type
PRIMARY
unit Of Measure
proportion of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice