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NCT01964300 · OUTCOME

Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery · Source last updated 2020-02-24

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 1 year

What was measured

Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.

Analysis population: Only eligible stratum 2 patients are included in this analysis. This is a \*secondary\* outcome measure for stratum 1 patients and is therefore reported as a separate outcome measure.

Groups in this outcome

Stratum 1

Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Stratum 2

Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Stratum 10
Stratum 211

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 20.0Not reported0.025.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        25.0
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Stratum 1
  2. description
    Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Stratum 2
param Type
NUMBER
population Description
Only eligible stratum 2 patients are included in this analysis. This is a \*secondary\* outcome measure for stratum 1 patients and is therefore reported as a separate outcome measure.
reporting Status
POSTED
time Frame
Up to 1 year
title
Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice