Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03257631 · OUTCOME

Kaplan-Meier Estimate of Overall Survival (OS)

A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors · Source last updated 2024-04-16

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of pomalidomide to the date of death due to any cause (Up to 71 months)

What was measured

Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.

Analysis population: The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not

Groups in this outcome

Diffuse Intrinsic Pontine Glioma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

Ependymoma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

High-grade Glioma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

Medulloblastoma

Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Diffuse Intrinsic Pontine Glioma11
Ependymoma9
High-grade Glioma23
Medulloblastoma10

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Diffuse Intrinsic Pontine Glioma4.86Not reported1.0210.91Not reported
Ependymoma12.02Not reported2.8620.90Not reported
High-grade Glioma5.06Not reported2.0416.66Not reported
Medulloblastoma11.60Not reported1.7435.32Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.02
        upper Limit
        10.91
        value
        4.86
      2. group Id
        OG001
        lower Limit
        2.86
        upper Limit
        20.90
        value
        12.02
      3. group Id
        OG002
        lower Limit
        2.04
        upper Limit
        16.66
        value
        5.06
      4. group Id
        OG003
        lower Limit
        1.74
        upper Limit
        35.32
        value
        11.60
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      23
    4. group Id
      OG003
      value
      10
    units
    Participants
description
Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    OG000
    title
    Diffuse Intrinsic Pontine Glioma
  2. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    OG001
    title
    Ependymoma
  3. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    OG002
    title
    High-grade Glioma
  4. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    OG003
    title
    Medulloblastoma
param Type
MEDIAN
population Description
The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
reporting Status
POSTED
time Frame
From the first dose of pomalidomide to the date of death due to any cause (Up to 71 months)
title
Kaplan-Meier Estimate of Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice