NCT00281840 · ADVERSE EVENTS

Adverse events

Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2015-06-09

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bevacizumab With Docetaxel and Radiation Therapy Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.	12 / 30	30 / 30	Not reported / Not reported

Group identifiers: EG000: Bevacizumab With Docetaxel and Radiation Therapy

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
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Thrombosis/embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Wound-Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
3
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Diarrhea patients without colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Gastrointestinal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
term
Infection without neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
4
term
Pneumonitis/pulmonary infiltrates
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
map to v4.0 as vascular disorder (other)
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Hemorrhage

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
30
num Events
39
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
30
num Events
46
term
Dysphagia, esophagitis, odynophagia (painful swallowing)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
28
term
Mouth dryness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
41
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
30
num Events
33
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
15
num At Risk
30
num Events
31
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
15
num At Risk
30
num Events
31
term
Mucositis due to radiation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
14
num At Risk
30
num Events
22
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
12
num At Risk
30
num Events
19
term
Diarrhea patients without colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
30
num Events
12
term
Gastrointestinal (congestion)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
30
num Events
18
term
Taste disturbance (dysgeusia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
30
num Events
13
term
Salivary gland changes

Complete source fields

event Groups

description
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
12
serious Num At Risk
30
title
Bevacizumab With Docetaxel and Radiation Therapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
20
num At Risk
30
num Events
39
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
30
num Events
46
term
Dysphagia, esophagitis, odynophagia (painful swallowing)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
28
term
Mouth dryness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
41
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
30
num Events
33
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
15
num At Risk
30
num Events
31
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
15
num At Risk
30
num Events
31
term
Mucositis due to radiation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
14
num At Risk
30
num Events
22
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
12
num At Risk
30
num Events
19
term
Diarrhea patients without colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
30
num Events
12
term
Gastrointestinal (congestion)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
30
num Events
18
term
Taste disturbance (dysgeusia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
30
num Events
13
term
Salivary gland changes

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Thrombosis/embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Wound-Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
3
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Diarrhea patients without colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Gastrointestinal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
term
Infection without neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
4
term
Pneumonitis/pulmonary infiltrates
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
map to v4.0 as vascular disorder (other)
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
term
Hemorrhage

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Preserved source evidence · Not medical advice