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NCT00068237 · OUTCOME

Percentage of Patients With Acute Xerostomia

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer · Source last updated 2019-02-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment to 90 days

What was measured

The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).

Analysis population: Eligible patients who started RT

Groups in this outcome

Surgery + Transfer + Radiation

Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.

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

Analysis denominator · Participants

GroupSource count
Surgery + Transfer + Radiation43

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Surgery + Transfer + Radiation25.6Not reported12.538.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.5
        upper Limit
        38.6
        value
        25.6
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).
dispersion Type
95% Confidence Interval
groups
  1. description
    Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
    id
    OG000
    title
    Surgery + Transfer + Radiation
param Type
NUMBER
population Description
Eligible patients who started RT
reporting Status
POSTED
time Frame
From start of treatment to 90 days
title
Percentage of Patients With Acute Xerostomia
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice