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NCT01682031 · OUTCOME

Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia

Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy · Source last updated 2014-08-22

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

Measure
NUMBER
Unit
number of xerostomia events
Interval / dispersion
Not reported
Time frame
Up to 5 years post-treatment

What was measured

Will be compared as difference in proportions with 95% confidence intervals.

Analysis population: All treated and eligible patients

Groups in this outcome

Arm I (Placebo, Cisplatin, and Radiotherapy)

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies

Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Placebo, Cisplatin, and Radiotherapy)8
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)10

Reported measurements

Source class 1
Values in number of xerostomia events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Placebo, Cisplatin, and Radiotherapy)1Not reportedNot reportedNot reportedNot reported
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Will be compared as difference in proportions with 95% confidence intervals.
groups
  1. description
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Placebo, Cisplatin, and Radiotherapy)
  2. description
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    id
    OG001
    title
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to 5 years post-treatment
title
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
type
SECONDARY
unit Of Measure
number of xerostomia events

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

Preserved source evidence · Not medical advice