Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00354835 · OUTCOME

Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma · Source last updated 2023-01-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Counts
Interval / dispersion
Not reported
Time frame
Weeks 4-9 (the first exposure to VI)

What was measured

Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.

Analysis population: Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.

Groups in this outcome

UGT1A1 Genotype 6/6

Not reported

UGT1A1 Genotype 6/7

Not reported

UGT1A1 Genotype 7/7

Not reported

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

Analysis denominator · Participants

GroupSource count
UGT1A1 Genotype 6/649
UGT1A1 Genotype 6/765
UGT1A1 Genotype 7/712

Reported measurements

Neutropenia, with or without Fever
Values in Counts · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGT1A1 Genotype 6/616Not reportedNot reportedNot reportedNot reported
UGT1A1 Genotype 6/722Not reportedNot reportedNot reportedNot reported
UGT1A1 Genotype 7/74Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Counts · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGT1A1 Genotype 6/65Not reportedNot reportedNot reportedNot reported
UGT1A1 Genotype 6/714Not reportedNot reportedNot reportedNot reported
UGT1A1 Genotype 7/75Not reportedNot reportedNot reportedNot 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 incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.99
    statistical Method
    Fisher Exact
  2. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.036
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.99
    statistical Method
    Fisher Exact
  2. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.036
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        4
    title
    Neutropenia, with or without Fever
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        5
    title
    Diarrhea
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      65
    3. group Id
      OG002
      value
      12
    units
    Participants
description
Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.
groups
  1. id
    OG000
    title
    UGT1A1 Genotype 6/6
  2. id
    OG001
    title
    UGT1A1 Genotype 6/7
  3. id
    OG002
    title
    UGT1A1 Genotype 7/7
param Type
NUMBER
population Description
Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.
reporting Status
POSTED
time Frame
Weeks 4-9 (the first exposure to VI)
title
Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype
type
SECONDARY
unit Of Measure
Counts

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

Preserved source evidence · Not medical advice