NCT00956007 · ADVERSE EVENTS

Adverse events

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer · Source last updated 2026-01-06

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: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
Other-event reporting threshold: 5%

All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
IMRT Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).	50 / 282	278 / 282	97 / 287
IMRT Plus Cetuximab Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.	83 / 276	275 / 276	87 / 290

Group identifiers: EG000: IMRT · EG001: IMRT Plus Cetuximab

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
282
group Id
EG001
num Affected
0
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
282
group Id
EG001
num Affected
0
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Eye disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Colonic perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
282
group Id
EG001
num Affected
2
num At Risk
276
term
Constipation

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
39
num At Risk
282
group Id
EG001
num Affected
74
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
17
num At Risk
282
group Id
EG001
num Affected
23
num At Risk
276
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
33
num At Risk
282
group Id
EG001
num Affected
40
num At Risk
276
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
282
group Id
EG001
num Affected
16
num At Risk
276
term
Hyperthyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
43
num At Risk
282
group Id
EG001
num Affected
53
num At Risk
276
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
282
group Id
EG001
num Affected
21
num At Risk
276
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
39
num At Risk
282
group Id
EG001
num Affected
80
num At Risk
276
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
282
group Id
EG001
num Affected
40
num At Risk
276
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
253
num At Risk
282
group Id
EG001
num Affected
246
num At Risk
276
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
282
group Id
EG001
num Affected
24
num At Risk
276
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
244
num At Risk
282
group Id
EG001
num Affected
250
num At Risk
276
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
50
num At Risk
282
group Id
EG001
num Affected
57
num At Risk
276
term
Gastrointestinal disorders - Other

Complete source fields

description

All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.

event Groups

deaths Num Affected
97
deaths Num At Risk
287
description
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
id
EG000
other Num Affected
278
other Num At Risk
282
serious Num Affected
50
serious Num At Risk
282
title
IMRT
deaths Num Affected
87
deaths Num At Risk
290
description
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
id
EG001
other Num Affected
275
other Num At Risk
276
serious Num Affected
83
serious Num At Risk
276
title
IMRT Plus Cetuximab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
39
num At Risk
282
group Id
EG001
num Affected
74
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
17
num At Risk
282
group Id
EG001
num Affected
23
num At Risk
276
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
33
num At Risk
282
group Id
EG001
num Affected
40
num At Risk
276
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
282
group Id
EG001
num Affected
16
num At Risk
276
term
Hyperthyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
43
num At Risk
282
group Id
EG001
num Affected
53
num At Risk
276
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
282
group Id
EG001
num Affected
21
num At Risk
276
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
39
num At Risk
282
group Id
EG001
num Affected
80
num At Risk
276
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
282
group Id
EG001
num Affected
40
num At Risk
276
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
253
num At Risk
282
group Id
EG001
num Affected
246
num At Risk
276
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
282
group Id
EG001
num Affected
24
num At Risk
276
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
244
num At Risk
282
group Id
EG001
num Affected
250
num At Risk
276
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
50
num At Risk
282
group Id
EG001
num Affected
57
num At Risk
276
term
Gastrointestinal disorders - Other

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
282
group Id
EG001
num Affected
0
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
282
group Id
EG001
num Affected
0
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Eye disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
282
group Id
EG001
num Affected
1
num At Risk
276
term
Colonic perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
282
group Id
EG001
num Affected
2
num At Risk
276
term
Constipation

time Frame

From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.

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Preserved source evidence · Not medical advice