NCT00360971 · OUTCOME

Time to Second Primary Tumor

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 occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no 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

Group	Source count
Placebo	8
Palifermin	11

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Palifermin	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
11
units
Participants

description

An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.

groups

description
Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
id
OG000
title
Placebo
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

Time to Second Primary Tumor

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice