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NCT00293462 · OUTCOME

Comparison of the Mean Number of Days for Mucositis to Heal Across by Group

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2021-07-30

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
From onset of mucositis to healing of mucositis, approximately 80 days

What was measured

The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.

Analysis population: Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash

Groups in this outcome

Arm I: GM-CSF Group (GG)

Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm II: Salt & Soda Group (SS)

Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm III: Salt & Soda Switched to GM-CSF (SG)

Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.

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

Analysis denominator · Participants

GroupSource count
Arm I: GM-CSF Group (GG)28
Arm II: Salt & Soda Group (SS)21
Arm III: Salt & Soda Switched to GM-CSF (SG)19

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I: GM-CSF Group (GG)81.563.43Not reportedNot reportedNot reported
Arm II: Salt & Soda Group (SS)79.431.24Not reportedNot reportedNot reported
Arm III: Salt & Soda Switched to GM-CSF (SG)77.437.40Not 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
    Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.92
    statistical Comment
    Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.92
    statistical Comment
    Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.43
        value
        81.5
      2. group Id
        OG001
        spread
        31.24
        value
        79.4
      3. group Id
        OG002
        spread
        37.40
        value
        77.4
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      19
    units
    Participants
description
The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.
dispersion Type
Standard Deviation
groups
  1. description
    Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    OG000
    title
    Arm I: GM-CSF Group (GG)
  2. description
    Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    OG001
    title
    Arm II: Salt & Soda Group (SS)
  3. description
    Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
    id
    OG002
    title
    Arm III: Salt & Soda Switched to GM-CSF (SG)
param Type
MEAN
population Description
Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash
reporting Status
POSTED
time Frame
From onset of mucositis to healing of mucositis, approximately 80 days
title
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
type
PRIMARY
unit Of Measure
days

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Preserved source evidence · Not medical advice