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NCT00567567 · OUTCOME

Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies

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
Micromolar
Interval / dispersion
Full Range
Time frame
Day 1 of each course

What was measured

Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532

Analysis population: Eligible patients evaluated for peak serum concentration level of isotretinoin.

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)91
Tandem HST (CEM), Randomly Assigned76
Not Assigned49

Reported measurements

Source class 1
Values in Micromolar · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Single HST (CEM)1.00Not reported09.22Not reported
Tandem HST (CEM), Randomly Assigned1.36Not reported012.93Not reported
Not Assigned1.26Not reported011.78Not 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 relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6853
    param Type
    Hazard Ratio (HR)
    param Value
    1.015
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6853
    param Type
    Hazard Ratio (HR)
    param Value
    1.015
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        9.22
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        12.93
        value
        1.36
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        11.78
        value
        1.26
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      76
    3. group Id
      OG002
      value
      49
    units
    Participants
description
Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532
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 evaluated for peak serum concentration level of isotretinoin.
reporting Status
POSTED
time Frame
Day 1 of each course
title
Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
type
SECONDARY
unit Of Measure
Micromolar

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Preserved source evidence · Not medical advice