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NCT00101582 · OUTCOME

Duration of Severe (WHO Grade 3 or 4) Oral Mucositis

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer · Source last updated 2016-09-27

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 15 weeks

What was measured

The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.

Analysis population: Full analysis set

Groups in this outcome

Placebo

Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.

Palifermin

Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.

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

Analysis denominator · Participants

GroupSource count
Placebo94
Palifermin94

Reported measurements

Source class 1
Values in days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Placebo26.0Not reported0.050.0Not reported
Palifermin5.0Not reported0.040.0Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0160
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for mean score difference.
    param Type
    Chi-Square Statistic
    param Value
    5.8002
    statistical Comment
    Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Description
    To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1122
    p Value Comment
    Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0160
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for mean score difference.
    param Type
    Chi-Square Statistic
    param Value
    5.8002
    statistical Comment
    Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Description
    To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1122
    p Value Comment
    Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        50.0
        value
        26.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        40.0
        value
        5.0
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      94
    units
    Participants
description
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
    id
    OG000
    title
    Placebo
  2. description
    Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
    id
    OG001
    title
    Palifermin
param Type
MEDIAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
Up to 15 weeks
title
Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice