NCT00352105 · ADVERSE EVENTS

Adverse events

Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer · Source last updated 2012-11-05

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: For 2 years of the study
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
5-FU, Cisplatin, Radiation and Iressa Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.	60 / 60	55 / 60	Not reported / Not reported

Group identifiers: EG000: 5-FU, Cisplatin, Radiation and Iressa

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
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
41
num At Risk
60
term
>= Grade 3 dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
52
num At Risk
60
term
>= Grade 3 mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
60
term
>=Grade 3:Nausea, vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
46
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
17
num At Risk
60
term
Renal Dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
60
term
Thrombocytopenia

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
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
52
num At Risk
60
term
Grade 1-2 :Nausea, vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
18
num At Risk
60
term
Grade 1-2 dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Grade 1-2 mucositis

Complete source fields

event Groups

description
Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
55
other Num At Risk
60
serious Num Affected
60
serious Num At Risk
60
title
5-FU, Cisplatin, Radiation and Iressa

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
52
num At Risk
60
term
Grade 1-2 :Nausea, vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
18
num At Risk
60
term
Grade 1-2 dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Grade 1-2 mucositis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
41
num At Risk
60
term
>= Grade 3 dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
52
num At Risk
60
term
>= Grade 3 mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
60
term
>=Grade 3:Nausea, vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
46
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
17
num At Risk
60
term
Renal Dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
60
term
Thrombocytopenia

time Frame

For 2 years of the study

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

Preserved source evidence · Not medical advice