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NCT00939627 · OUTCOME

Number of Participants With Each Worst-Grade Toxicity

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab · Source last updated 2026-03-10

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
On-study date to 30 days following final dose of study drug

What was measured

Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death

Analysis population: Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.

Groups in this outcome

Arm A - Cetuximab

Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.

Arm B - Cetuximab and Sorafenib Tosylate

Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.

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 A - Cetuximab23
Arm B - Cetuximab and Sorafenib Tosylate24

Reported measurements

Number of Patients with Worst-Grade Toxicity 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab6Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate7Not reportedNot reportedNot reportedNot reported
Number of Patients with Worst-Grade Toxicity 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab11Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate4Not reportedNot reportedNot reportedNot reported
Number of Patients with Worst-Grade Toxicity 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab5Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate12Not reportedNot reportedNot reportedNot reported
Number of Patients with Worst-Grade Toxicity 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab1Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate1Not reportedNot reportedNot reportedNot reported
Number of Patients with Worst-Grade Toxicity 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab0Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
    title
    Number of Patients with Worst-Grade Toxicity 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        4
    title
    Number of Patients with Worst-Grade Toxicity 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        12
    title
    Number of Patients with Worst-Grade Toxicity 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Number of Patients with Worst-Grade Toxicity 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Number of Patients with Worst-Grade Toxicity 5
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death
groups
  1. description
    Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
    id
    OG000
    title
    Arm A - Cetuximab
  2. description
    Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
    id
    OG001
    title
    Arm B - Cetuximab and Sorafenib Tosylate
param Type
NUMBER
population Description
Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.
reporting Status
POSTED
time Frame
On-study date to 30 days following final dose of study drug
title
Number of Participants With Each Worst-Grade Toxicity
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice