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NCT00360971 · OUTCOME

Duration of Oral Mucositis as Measured in Terms of Days

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer · Source last updated 2017-12-26

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
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

What was measured

Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.

Analysis population: All eligible patients.

Groups in this outcome

Placebo

Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.

Palifermin

Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.

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

Analysis denominator · Participants

GroupSource count
Placebo10
Palifermin11

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3224Not reportedNot reportedNot reported
Palifermin1323Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24
        value
        32
      2. group Id
        OG001
        spread
        23
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.
dispersion Type
Standard Deviation
groups
  1. description
    Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
    id
    OG000
    title
    Placebo
  2. description
    Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
    id
    OG001
    title
    Palifermin
param Type
MEAN
population Description
All eligible patients.
reporting Status
POSTED
time Frame
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
title
Duration of Oral Mucositis as Measured in Terms of Days
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice