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NCT00360971 · OUTCOME

Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale

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

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Analysis population: All randomized 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
Placebo4810Not reportedNot reportedNot reported
Palifermin416Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10
        value
        48
      2. group Id
        OG001
        spread
        6
        value
        41
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
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 randomized patients
reporting Status
POSTED
time Frame
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
title
Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice