NCT00700102 · ADVERSE EVENTS

Adverse events

A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer. · Source last updated 2015-07-30

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: First subject first visit to end of trial within 7.25 years
Other-event reporting threshold: 5%

Safety Analysis Set was defined as all randomized patients who received any amount of study treatment, and were analyzed according to actual treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Chemotherapy Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal	137 / 409	379 / 409	Not reported / Not reported
Chemotherapy + Bevacizumab Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal	130 / 401	382 / 401	Not reported / Not reported

Group identifiers: EG000: Chemotherapy · EG001: Chemotherapy + Bevacizumab

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
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
409
num Events
3
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Abdominal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
9
num At Risk
409
num Events
9
group Id
EG001
num Affected
6
num At Risk
401
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
409
num Events
2
group Id
EG001
num Affected
1
num At Risk
401
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
409
num Events
2
group Id
EG001
num Affected
1
num At Risk
401
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
16
num At Risk
409
num Events
16
group Id
EG001
num Affected
13
num At Risk
401
num Events
13
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
409
num Events
0
group Id
EG001
num Affected
3
num At Risk
401
num Events
3
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
409
num Events
0
group Id
EG001
num Affected
2
num At Risk
401
num Events
2
term
Enterovesical fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Gastrointestinal disorder

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
MedDRA (16.0)
stats
group Id
EG000
num Affected
177
num At Risk
409
num Events
333
group Id
EG001
num Affected
233
num At Risk
401
num Events
471
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
170
num At Risk
409
num Events
294
group Id
EG001
num Affected
178
num At Risk
401
num Events
340
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
104
num At Risk
409
num Events
162
group Id
EG001
num Affected
119
num At Risk
401
num Events
188
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
76
num At Risk
409
num Events
91
group Id
EG001
num Affected
89
num At Risk
401
num Events
126
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
74
num At Risk
409
num Events
96
group Id
EG001
num Affected
82
num At Risk
401
num Events
120
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
32
num At Risk
409
num Events
47
group Id
EG001
num Affected
40
num At Risk
401
num Events
69
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
22
num At Risk
409
num Events
31
group Id
EG001
num Affected
37
num At Risk
401
num Events
44
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
106
num At Risk
409
num Events
263
group Id
EG001
num Affected
106
num At Risk
401
num Events
246
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
80
num At Risk
409
num Events
126
group Id
EG001
num Affected
94
num At Risk
401
num Events
154
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
43
num At Risk
409
num Events
72
group Id
EG001
num Affected
76
num At Risk
401
num Events
136
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
44
num At Risk
409
num Events
61
group Id
EG001
num Affected
66
num At Risk
401
num Events
92
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
26
num At Risk
409
num Events
30
group Id
EG001
num Affected
20
num At Risk
401
num Events
23
term
Oedema peripheral

Complete source fields

description

Safety Analysis Set was defined as all randomized patients who received any amount of study treatment, and were analyzed according to actual treatment received.

event Groups

description
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
id
EG000
other Num Affected
379
other Num At Risk
409
serious Num Affected
137
serious Num At Risk
409
title
Chemotherapy
description
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
id
EG001
other Num Affected
382
other Num At Risk
401
serious Num Affected
130
serious Num At Risk
401
title
Chemotherapy + Bevacizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
177
num At Risk
409
num Events
333
group Id
EG001
num Affected
233
num At Risk
401
num Events
471
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
170
num At Risk
409
num Events
294
group Id
EG001
num Affected
178
num At Risk
401
num Events
340
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
104
num At Risk
409
num Events
162
group Id
EG001
num Affected
119
num At Risk
401
num Events
188
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
76
num At Risk
409
num Events
91
group Id
EG001
num Affected
89
num At Risk
401
num Events
126
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
74
num At Risk
409
num Events
96
group Id
EG001
num Affected
82
num At Risk
401
num Events
120
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
32
num At Risk
409
num Events
47
group Id
EG001
num Affected
40
num At Risk
401
num Events
69
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
22
num At Risk
409
num Events
31
group Id
EG001
num Affected
37
num At Risk
401
num Events
44
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
106
num At Risk
409
num Events
263
group Id
EG001
num Affected
106
num At Risk
401
num Events
246
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
80
num At Risk
409
num Events
126
group Id
EG001
num Affected
94
num At Risk
401
num Events
154
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
43
num At Risk
409
num Events
72
group Id
EG001
num Affected
76
num At Risk
401
num Events
136
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
44
num At Risk
409
num Events
61
group Id
EG001
num Affected
66
num At Risk
401
num Events
92
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
26
num At Risk
409
num Events
30
group Id
EG001
num Affected
20
num At Risk
401
num Events
23
term
Oedema peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
409
num Events
3
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Abdominal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
9
num At Risk
409
num Events
9
group Id
EG001
num Affected
6
num At Risk
401
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
409
num Events
2
group Id
EG001
num Affected
1
num At Risk
401
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
409
num Events
2
group Id
EG001
num Affected
1
num At Risk
401
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
16
num At Risk
409
num Events
16
group Id
EG001
num Affected
13
num At Risk
401
num Events
13
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
409
num Events
0
group Id
EG001
num Affected
3
num At Risk
401
num Events
3
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
409
num Events
0
group Id
EG001
num Affected
2
num At Risk
401
num Events
2
term
Enterovesical fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
409
num Events
1
group Id
EG001
num Affected
0
num At Risk
401
num Events
0
term
Gastrointestinal disorder

time Frame

First subject first visit to end of trial within 7.25 years

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Preserved source evidence · Not medical advice