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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 for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.

Analysis population: Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.

Groups in this outcome

Regimen A

Randomized to Regimen A - RA Only

Regimen B

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 A93
Regimen B127

Reported measurements

Randomized patients with INSS Stage 4 disease

Analysis denominator · Participants

GroupSource count
Regimen A93
Regimen B90
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A43.2Not reported32.553.8Not reported
Regimen B59.7Not reported49.569.9Not reported
Eligible patients with persistent disease

Analysis denominator · Participants

GroupSource count
Regimen A0
Regimen B37
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen B35.1Not reported19.850.5Not 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 for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1057
    param Type
    Log Rank Test Statistic
    param Value
    2.6176
    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 for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1057
    param Type
    Log Rank Test Statistic
    param Value
    2.6176
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.5
        upper Limit
        53.8
        value
        43.2
      2. group Id
        OG001
        lower Limit
        49.5
        upper Limit
        69.9
        value
        59.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      2. group Id
        OG001
        value
        90
      units
      Participants
    title
    Randomized patients with INSS Stage 4 disease
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        19.8
        upper Limit
        50.5
        value
        35.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Eligible patients with persistent disease
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      127
    units
    Participants
description
Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomized to Regimen A - RA Only
    id
    OG000
    title
    Regimen A
  2. description
    Regimen B - RA + Immunotherapy
    id
    OG001
    title
    Regimen B
param Type
NUMBER
population Description
Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.
reporting Status
POSTED
time Frame
Three years
title
Event-Free Survival (EFS)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice