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NCT00524017 · OUTCOME

Number of Participants With Objective Response Based on Histologic Grade

Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract · Source last updated 2020-03-12

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
8 weeks

What was measured

Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).

Groups in this outcome

Arm I (Treatment)

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. cetuximab: given IV

Arm II (Control)

Patients receive regular follow-up care

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 (Treatment)13
Arm II (Control)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Treatment)13Not reportedNot reportedNot reportedNot reported
Arm II (Control)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).
groups
  1. description
    Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. cetuximab: given IV
    id
    OG000
    title
    Arm I (Treatment)
  2. description
    Patients receive regular follow-up care
    id
    OG001
    title
    Arm II (Control)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
8 weeks
title
Number of Participants With Objective Response Based on Histologic Grade
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice