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NCT00567567 · OUTCOME

Duration of Greater Than or Equal to Grade 3 Neutropenia

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
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days

What was measured

A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.

Analysis population: Eligible patients with available polymorphism and neutropenia toxicity data.

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)117
Tandem HST (CEM), Randomly Assigned103
Not Assigned129

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Single HST (CEM)7Not reported020Not reported
Tandem HST (CEM), Randomly Assigned7Not reported039Not reported
Not Assigned7Not reported035Not 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 Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0939
    param Type
    Slope
    param Value
    -0.0557
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0939
    param Type
    Slope
    param Value
    -0.0557
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        20
        value
        7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        39
        value
        7
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        35
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      103
    3. group Id
      OG002
      value
      129
    units
    Participants
description
A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.
dispersion Type
Full Range
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
MEDIAN
population Description
Eligible patients with available polymorphism and neutropenia toxicity data.
reporting Status
POSTED
time Frame
Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days
title
Duration of Greater Than or Equal to Grade 3 Neutropenia
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice