NCT00545792 · ADVERSE EVENTS

Adverse events

Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers · Source last updated 2017-03-15

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: 1 year
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Avastin Avastin and daily radiation Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.	8 / 20	20 / 20	Not reported / Not reported

Group identifiers: EG000: Avastin

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
notes
Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 3.0
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v 3.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Thrombosis/thrombus/embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Portal Vein Flow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Hemorrhage, GI

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 (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
20
num Events
42
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
2
term
Vascular event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
20
term
Genitourinary/bladder event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
14
term
Pulmonary event
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
20
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
20
num Events
35
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
20
num Events
66
term
Leukocytes
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1-3
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
20
num Events
63
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
term
Neutrophils/granulocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
14
num At Risk
20
num Events
28
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Palpitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
20
num Events
14
term
Hypertension

Complete source fields

event Groups

description
Avastin and daily radiation Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Avastin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
20
num Events
42
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
2
term
Vascular event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
20
term
Genitourinary/bladder event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
14
term
Pulmonary event
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
20
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
20
num Events
35
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
20
num Events
66
term
Leukocytes
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1-3
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
17
num At Risk
20
num Events
63
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
term
Neutrophils/granulocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
14
num At Risk
20
num Events
28
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Palpitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
20
num Events
14
term
Hypertension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 3.0
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v 3.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Thrombosis/thrombus/embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Portal Vein Flow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Hemorrhage, GI

time Frame

1 year

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Preserved source evidence · Not medical advice