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NCT00360971 · OUTCOME

Progression-free Survival

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to maximum follow-up at time of analysis of 21 months

What was measured

An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.

Analysis population: Randomized patients who started protocol treatment

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
Placebo8
Palifermin11

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo2Not reportedNot reportedNot reportedNot reported
Palifermin0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      11
    units
    Participants
description
An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.
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
COUNT_OF_PARTICIPANTS
population Description
Randomized patients who started protocol treatment
reporting Status
POSTED
time Frame
From randomization to maximum follow-up at time of analysis of 21 months
title
Progression-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice