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NCT03389802 · OUTCOME

Overall Survival for Stratum 2 (DIPG) Patients

Phase I Study of APX005M in Pediatric Central Nervous System Tumors · Source last updated 2026-08-13

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

Measure
NUMBER
Unit
Percent probability
Interval / dispersion
95% Confidence Interval
Time frame
1 year

What was measured

Overall survival was defined as the time interval from treatment initiation to death from any cause or to date of last follow-up for survivors. Survival was estimated using the method of Kaplan and Meier. The 1-year estimate of survival is reported with a 95% confidence interval; estimates are reported by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

Analysis population: Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M were included in this analysis.

Groups in this outcome

Stratum 2, Dose Level 2

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

Stratum 2, Dose Level 3

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

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 2, Dose Level 26
Stratum 2, Dose Level 35

Reported measurements

Source class 1
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 2, Dose Level 240.0Not reported4.975.1Not reported
Stratum 2, Dose Level 325.0Not reported0.055.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.9
        upper Limit
        75.1
        value
        40.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        55.0
        value
        25.0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Overall survival was defined as the time interval from treatment initiation to death from any cause or to date of last follow-up for survivors. Survival was estimated using the method of Kaplan and Meier. The 1-year estimate of survival is reported with a 95% confidence interval; estimates are reported by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    OG000
    title
    Stratum 2, Dose Level 2
  2. description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    OG001
    title
    Stratum 2, Dose Level 3
param Type
NUMBER
population Description
Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M were included in this analysis.
reporting Status
POSTED
time Frame
1 year
title
Overall Survival for Stratum 2 (DIPG) Patients
type
SECONDARY
unit Of Measure
Percent probability

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

Preserved source evidence · Not medical advice