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NCT02343224 · OUTCOME

Number of Children Responding to Treatment

Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas · Source last updated 2022-01-24

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Month 12

What was measured

The objective response of study participants was categorized as complete response, partial response, or stable disease. Determination of tumor response or progression is based on the pre-study baseline scan performed closest to time of study entry. The overall response assessment takes into account response in both target and non-target lesion, and the appearance of new lesions. Complete response is defined as the disappearance of all target lesions and non-target lesions, and no new lesions. Partial response is defined as ≥ 65% decrease in the sum of the products of the three perpendicular diameters of all target lesions, and no development of new lesions. Stable disease is defined as neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for partial response, nor sufficient increase in a single target lesion to qualify for progressive disease, as well as no new lesions.

Groups in this outcome

PEGINTRON

Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years

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

Analysis denominator · Participants

GroupSource count
PEGINTRON9

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGINTRON0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGINTRON0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGINTRON5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The objective response of study participants was categorized as complete response, partial response, or stable disease. Determination of tumor response or progression is based on the pre-study baseline scan performed closest to time of study entry. The overall response assessment takes into account response in both target and non-target lesion, and the appearance of new lesions. Complete response is defined as the disappearance of all target lesions and non-target lesions, and no new lesions. Partial response is defined as ≥ 65% decrease in the sum of the products of the three perpendicular diameters of all target lesions, and no development of new lesions. Stable disease is defined as neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for partial response, nor sufficient increase in a single target lesion to qualify for progressive disease, as well as no new lesions.
groups
  1. description
    Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years
    id
    OG000
    title
    PEGINTRON
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Month 12
title
Number of Children Responding to Treatment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice