NCT00939627 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 2 years, 4 months
Other-event reporting threshold: 0%

All participants who received treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A - Cetuximab Patients were to receive cetuximab 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.	5 / 26	25 / 26	Not reported / Not reported
Arm B - Cetuximab and Sorafenib Tosylate Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.	10 / 27	27 / 27	Not reported / Not reported

Group identifiers: EG000: Arm A - Cetuximab · EG001: Arm B - Cetuximab and Sorafenib Tosylate

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
3
num At Risk
27
num Events
3
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
2
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Esophageal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Hyperkalemia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
19
num At Risk
26
num Events
31
group Id
EG001
num Affected
18
num At Risk
27
num Events
27
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
group Id
EG001
num Affected
6
num At Risk
27
num Events
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
3
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Edema - limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
10
num At Risk
26
num Events
11
group Id
EG001
num Affected
8
num At Risk
27
num Events
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
7
num At Risk
26
num Events
11
group Id
EG001
num Affected
7
num At Risk
27
num Events
11
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
group Id
EG001
num Affected
10
num At Risk
27
num Events
14
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
3
group Id
EG001
num Affected
5
num At Risk
27
num Events
7
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
group Id
EG001
num Affected
4
num At Risk
27
num Events
5
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
5
num At Risk
27
num Events
6
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
4
num At Risk
27
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
3
num At Risk
27
num Events
3
term
Gastroesophageal reflux disease

Complete source fields

description

All participants who received treatment.

event Groups

description
Patients were to receive cetuximab 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
EG000
other Num Affected
25
other Num At Risk
26
serious Num Affected
5
serious Num At Risk
26
title
Arm A - Cetuximab
description
Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
id
EG001
other Num Affected
27
other Num At Risk
27
serious Num Affected
10
serious Num At Risk
27
title
Arm B - Cetuximab and Sorafenib Tosylate

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
19
num At Risk
26
num Events
31
group Id
EG001
num Affected
18
num At Risk
27
num Events
27
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
group Id
EG001
num Affected
6
num At Risk
27
num Events
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
3
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Edema - limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
10
num At Risk
26
num Events
11
group Id
EG001
num Affected
8
num At Risk
27
num Events
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
7
num At Risk
26
num Events
11
group Id
EG001
num Affected
7
num At Risk
27
num Events
11
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
group Id
EG001
num Affected
10
num At Risk
27
num Events
14
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
3
group Id
EG001
num Affected
5
num At Risk
27
num Events
7
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
group Id
EG001
num Affected
4
num At Risk
27
num Events
5
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
5
num At Risk
27
num Events
6
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
4
num At Risk
27
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
3
num At Risk
27
num Events
3
term
Gastroesophageal reflux disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
3
num At Risk
27
num Events
3
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
2
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Esophageal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
26
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
term
Hyperkalemia

time Frame

2 years, 4 months

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Preserved source evidence · Not medical advice