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NCT00026312 · OUTCOME

Event-Free Survival (EFS)

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma · Source last updated 2026-03-05

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
Three years

What was measured

Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only

Analysis population: Eligible, randomized patients.

Groups in this outcome

Regimen A

Randomized to Regimen A - RA Only

Regimen B

Randomized to Regimen B - RA + Immunotherapy

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

Analysis denominator · Participants

GroupSource count
Regimen A112
Regimen B114

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A48.1Not reported38.457.8Not reported
Regimen B62.9Not reported54.071.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1016
    param Type
    Log Rank Test Statistic
    param Value
    2.6803
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1016
    param Type
    Log Rank Test Statistic
    param Value
    2.6803
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.4
        upper Limit
        57.8
        value
        48.1
      2. group Id
        OG001
        lower Limit
        54.0
        upper Limit
        71.9
        value
        62.9
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomized to Regimen A - RA Only
    id
    OG000
    title
    Regimen A
  2. description
    Randomized to Regimen B - RA + Immunotherapy
    id
    OG001
    title
    Regimen B
param Type
NUMBER
population Description
Eligible, randomized patients.
reporting Status
POSTED
time Frame
Three years
title
Event-Free Survival (EFS)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice