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NCT00608205 · OUTCOME

Pain

Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2020-08-06

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
24 months from start of treatment

What was measured

Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Analysis population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Groups in this outcome

Arm A

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Arm B

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

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 A20
Arm B16

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A0.600.75Not reportedNot reportedNot reported
Arm B0.751.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.75
        value
        0.60
      2. group Id
        OG001
        spread
        1.00
        value
        0.75
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      16
    units
    Participants
description
Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
dispersion Type
Standard Deviation
groups
  1. description
    Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
    id
    OG000
    title
    Arm A
  2. description
    Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
    id
    OG001
    title
    Arm B
param Type
MEAN
population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
reporting Status
POSTED
time Frame
24 months from start of treatment
title
Pain
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice