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NCT00101582 · OUTCOME

Time to Onset 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

Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.

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
Placebo35.0Not reported22.0NACould not be estimated due to the low number of events
Palifermin47.0Not reported27.0NACould not be estimated due to the low number of events

Source statistical analyses

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

  1. ci Lower Limit
    0.4546
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9592
    estimate Comment
    Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0261
    param Type
    Hazard Ratio (HR)
    param Value
    0.6603
    statistical Comment
    Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1566
    p Value Comment
    Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.4546
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9592
    estimate Comment
    Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0261
    param Type
    Hazard Ratio (HR)
    param Value
    0.6603
    statistical Comment
    Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1566
    p Value Comment
    Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the low number of events
        group Id
        OG000
        lower Limit
        22.0
        upper Limit
        NA
        value
        35.0
      2. comment
        Could not be estimated due to the low number of events
        group Id
        OG001
        lower Limit
        27.0
        upper Limit
        NA
        value
        47.0
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      94
    units
    Participants
description
Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.
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
Time to Onset 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