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NCT00026312 · OUTCOME

Overall Survival (OS)

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 OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.

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

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

Randomized patients

Analysis denominator · Participants

GroupSource count
Regimen A112
Regimen B114
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A67.4Not reported58.376.5Not reported
Regimen B78.8Not reported71.286.4Not reported
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 A64.0Not reported53.874.3Not reported
Regimen B78.7Not reported70.287.2Not 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 overall 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
    0.0634
    param Type
    Log Rank Test Statistic
    param Value
    3.4471
    statistical Method
    Log Rank
  2. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The overall 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
    0.042
    param Type
    Log-Rank Test Statistic
    param Value
    4.1362
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The overall 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
    0.0634
    param Type
    Log Rank Test Statistic
    param Value
    3.4471
    statistical Method
    Log Rank
  2. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The overall 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
    0.042
    param Type
    Log-Rank Test Statistic
    param Value
    4.1362
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.3
        upper Limit
        76.5
        value
        67.4
      2. group Id
        OG001
        lower Limit
        71.2
        upper Limit
        86.4
        value
        78.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    Randomized patients
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.8
        upper Limit
        74.3
        value
        64.0
      2. group Id
        OG001
        lower Limit
        70.2
        upper Limit
        87.2
        value
        78.7
    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
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 OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.
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. Eligible, randomized patients with INSS Stage 4 disease.
reporting Status
POSTED
time Frame
Three years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice