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NCT00101582 · OUTCOME

Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Month 4

What was measured

The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.

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

Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo57Not reportedNot reportedNot reportedNot reported
Palifermin37Not reportedNot reportedNot reportedNot reported
No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo19Not reportedNot reportedNot reportedNot reported
Palifermin31Not reportedNot reportedNot reportedNot reported
Unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo18Not reportedNot reportedNot reportedNot reported
Palifermin26Not reportedNot reportedNot reportedNot 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
    0.0463
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.
    param Type
    Chi-Square Statistic
    param Value
    3.9715
    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 Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2314
    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
    0.0463
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.
    param Type
    Chi-Square Statistic
    param Value
    3.9715
    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 Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2314
    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
        value
        57
      2. group Id
        OG001
        value
        37
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        31
    title
    No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        26
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      94
    units
    Participants
description
The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.
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
NUMBER
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
Month 4
title
Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice