NCT00096174 · ADVERSE EVENTS

Adverse events

Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-06-29

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: Assessed weekly while on treatment, and every 3 months for 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cisplatin, C225, Radiation * Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.	64 / 66	66 / 66	Not reported / Not reported

Group identifiers: EG000: Cisplatin, C225, Radiation

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
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Hearing w/w-o audiogr in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Hearing w/w-o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
66
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
66
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
66
term
Neutrophenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
66
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Insomnia

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
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
66
term
Hearing w/o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
66
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
60
num At Risk
66
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
55
num At Risk
66
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
34
num At Risk
66
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
66
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
66
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
55
num At Risk
66
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
66
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
66
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Rigor/chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
57
num At Risk
66
term
Weight loss

Complete source fields

event Groups

description
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
id
EG000
other Num Affected
66
other Num At Risk
66
serious Num Affected
64
serious Num At Risk
66
title
Cisplatin, C225, Radiation

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
66
term
Hearing w/o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
66
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
60
num At Risk
66
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
55
num At Risk
66
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
34
num At Risk
66
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
66
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
66
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
55
num At Risk
66
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
66
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
66
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Rigor/chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
57
num At Risk
66
term
Weight loss

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Hearing w/w-o audiogr in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Hearing w/w-o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
66
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
66
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
66
term
Neutrophenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
66
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
15
num At Risk
66
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
66
term
Insomnia

time Frame

Assessed weekly while on treatment, and every 3 months for 2 years

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Preserved source evidence · Not medical advice