Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00567567 · OUTCOME

Proportion of Patients With a Polymorphism

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
Proportion of patients
Interval / dispersion
Not reported
Time frame
Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days

What was measured

A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.

Analysis population: Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.

Groups in this outcome

Single HST (CEM)

Induction therapy + single myeloablative consolidation

Tandem HST (CEM), Randomly Assigned

Induction therapy + tandem myeloablative consolidation

Not Assigned

Patients that either failed during Induction therapy or refused randomization

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)101
Tandem HST (CEM), Randomly Assigned92
Not Assigned109

Reported measurements

Source class 1
Values in Proportion of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Single HST (CEM)0.96Not reportedNot reportedNot reportedNot reported
Tandem HST (CEM), Randomly Assigned0.96Not reportedNot reportedNot reportedNot reported
Not Assigned0.97Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.4105
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.001
    group Description
    Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.7598
    param Type
    Odds Ratio (OR)
    param Value
    1.4328
    statistical Comment
    Fisher's exact test was used instead of chi-square test due to small expected cell counts.
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    0.4105
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.001
    group Description
    Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.7598
    param Type
    Odds Ratio (OR)
    param Value
    1.4328
    statistical Comment
    Fisher's exact test was used instead of chi-square test due to small expected cell counts.
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.96
      2. group Id
        OG001
        value
        0.96
      3. group Id
        OG002
        value
        0.97
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      92
    3. group Id
      OG002
      value
      109
    units
    Participants
description
A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.
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
  3. description
    Patients that either failed during Induction therapy or refused randomization
    id
    OG002
    title
    Not Assigned
param Type
NUMBER
population Description
Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.
reporting Status
POSTED
time Frame
Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days
title
Proportion of Patients With a Polymorphism
type
SECONDARY
unit Of Measure
Proportion of patients

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

Preserved source evidence · Not medical advice