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NCT00101582 · OUTCOME

Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks

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
MEAN
Unit
mg of IV morphine equivalents
Interval / dispersion
Standard Deviation
Time frame
Up to 15 weeks

What was measured

The total dose of opioid analgesics (mg of intravenous \[IV\] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents.

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 mg of IV morphine equivalents · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1219.551769.29Not reportedNot reportedNot reported
Palifermin1243.312700.28Not 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
    0.2384
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.
    param Type
    Chi-Square Statistic
    param Value
    1.3901
    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
    0.6835
    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
    0.2384
    p Value Comment
    Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.
    param Type
    Chi-Square Statistic
    param Value
    1.3901
    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
    0.6835
    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
        spread
        1769.29
        value
        1219.55
      2. group Id
        OG001
        spread
        2700.28
        value
        1243.31
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      94
    units
    Participants
description
The total dose of opioid analgesics (mg of intravenous \[IV\] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents.
dispersion Type
Standard Deviation
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
MEAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
Up to 15 weeks
title
Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
type
SECONDARY
unit Of Measure
mg of IV morphine equivalents

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

Preserved source evidence · Not medical advice