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NCT00084318 · OUTCOME

Frequency of Other Acute and Late Toxicity

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck · Source last updated 2018-12-12

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
Not reported
Time frame
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.

What was measured

Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.

Analysis population: Eligible patients who started protocol treatment and did not withdraw consent

Groups in this outcome

RT+Cisplatin+Cetuximab

Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.

RT+Docetaxel+Cetuximab

Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.

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

Analysis denominator · Participants

GroupSource count
RT+Cisplatin+Cetuximab97
RT+Docetaxel+Cetuximab106

Reported measurements

Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab1.0Not reportedNot reportedNot reportedNot reported
RT+Docetaxel+Cetuximab0.0Not reportedNot reportedNot reportedNot reported
Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab10.3Not reportedNot reportedNot reportedNot reported
RT+Docetaxel+Cetuximab9.4Not reportedNot reportedNot reportedNot reported
Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab74.2Not reportedNot reportedNot reportedNot reported
RT+Docetaxel+Cetuximab73.6Not reportedNot reportedNot reportedNot reported
Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab14.4Not reportedNot reportedNot reportedNot reported
RT+Docetaxel+Cetuximab16.0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab0.0Not reportedNot reportedNot reportedNot reported
RT+Docetaxel+Cetuximab0.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.0
      2. group Id
        OG001
        value
        0.0
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10.3
      2. group Id
        OG001
        value
        9.4
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        74.2
      2. group Id
        OG001
        value
        73.6
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14.4
      2. group Id
        OG001
        value
        16.0
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.9
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      106
    units
    Participants
description
Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.
groups
  1. description
    Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
    id
    OG000
    title
    RT+Cisplatin+Cetuximab
  2. description
    Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
    id
    OG001
    title
    RT+Docetaxel+Cetuximab
param Type
NUMBER
population Description
Eligible patients who started protocol treatment and did not withdraw consent
reporting Status
POSTED
time Frame
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
title
Frequency of Other Acute and Late Toxicity
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice