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NCT00567567 · OUTCOME

Event-free Survival Rate

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma · Source last updated 2022-04-28

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
Three years, from time of randomization

What was measured

Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)

Analysis population: All eligible, randomized patients.

Groups in this outcome

Single HST (CEM)

Induction therapy + single myeloablative consolidation

Tandem HST (CEM), Randomly Assigned

Induction therapy + tandem myeloablative consolidation

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

Analysis denominator · Participants

GroupSource count
Single HST (CEM)179
Tandem HST (CEM), Randomly Assigned176

Reported measurements

Source class 1
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Single HST (CEM)48.8Not reported41.156.5Not reported
Tandem HST (CEM), Randomly Assigned61.8Not reported53.869.8Not 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 - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0082
    param Type
    Log Rank Test Statistic
    param Value
    6.9883
    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 - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0082
    param Type
    Log Rank Test Statistic
    param Value
    6.9883
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.1
        upper Limit
        56.5
        value
        48.8
      2. group Id
        OG001
        lower Limit
        53.8
        upper Limit
        69.8
        value
        61.8
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      176
    units
    Participants
description
Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction therapy + single myeloablative consolidation
    id
    OG000
    title
    Single HST (CEM)
  2. description
    Induction therapy + tandem myeloablative consolidation
    id
    OG001
    title
    Tandem HST (CEM), Randomly Assigned
param Type
NUMBER
population Description
All eligible, randomized patients.
reporting Status
POSTED
time Frame
Three years, from time of randomization
title
Event-free Survival Rate
type
PRIMARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice