NCT00112918 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer · Source last updated 2013-08-27

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: All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
FOLFOX4 Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.	226 / 1126	1112 / 1126	Not reported / Not reported
FOLFOX4 + Bv Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).	297 / 1145	1127 / 1145	Not reported / Not reported
XELOX+Bv Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).	284 / 1135	1117 / 1135	Not reported / Not reported

Group identifiers: EG000: FOLFOX4 · EG001: FOLFOX4 + Bv · EG002: XELOX+Bv

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 (13.0)
stats
group Id
EG000
num Affected
28
num At Risk
1126
group Id
EG001
num Affected
28
num At Risk
1145
group Id
EG002
num Affected
62
num At Risk
1135
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
11
num At Risk
1126
group Id
EG001
num Affected
14
num At Risk
1145
group Id
EG002
num Affected
18
num At Risk
1135
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
1126
group Id
EG001
num Affected
11
num At Risk
1145
group Id
EG002
num Affected
16
num At Risk
1135
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
6
num At Risk
1126
group Id
EG001
num Affected
9
num At Risk
1145
group Id
EG002
num Affected
7
num At Risk
1135
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
7
num At Risk
1135
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
7
num At Risk
1145
group Id
EG002
num Affected
3
num At Risk
1135
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
3
num At Risk
1126
group Id
EG001
num Affected
0
num At Risk
1145
group Id
EG002
num Affected
5
num At Risk
1135
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
1126
group Id
EG001
num Affected
2
num At Risk
1145
group Id
EG002
num Affected
4
num At Risk
1135
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
1126
group Id
EG001
num Affected
1
num At Risk
1145
group Id
EG002
num Affected
5
num At Risk
1135
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
1126
group Id
EG001
num Affected
0
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Abdominal adhesions

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 (13.0)
stats
group Id
EG000
num Affected
725
num At Risk
1126
group Id
EG001
num Affected
761
num At Risk
1145
group Id
EG002
num Affected
720
num At Risk
1135
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
620
num At Risk
1126
group Id
EG001
num Affected
699
num At Risk
1145
group Id
EG002
num Affected
699
num At Risk
1135
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
385
num At Risk
1126
group Id
EG001
num Affected
394
num At Risk
1145
group Id
EG002
num Affected
460
num At Risk
1135
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
310
num At Risk
1126
group Id
EG001
num Affected
360
num At Risk
1145
group Id
EG002
num Affected
246
num At Risk
1135
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
308
num At Risk
1126
group Id
EG001
num Affected
324
num At Risk
1145
group Id
EG002
num Affected
219
num At Risk
1135
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
220
num At Risk
1126
group Id
EG001
num Affected
227
num At Risk
1145
group Id
EG002
num Affected
214
num At Risk
1135
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
126
num At Risk
1126
group Id
EG001
num Affected
162
num At Risk
1145
group Id
EG002
num Affected
84
num At Risk
1135
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
86
num At Risk
1126
group Id
EG001
num Affected
118
num At Risk
1145
group Id
EG002
num Affected
113
num At Risk
1135
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
29
num At Risk
1126
group Id
EG001
num Affected
68
num At Risk
1145
group Id
EG002
num Affected
41
num At Risk
1135
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
430
num At Risk
1126
group Id
EG001
num Affected
430
num At Risk
1145
group Id
EG002
num Affected
436
num At Risk
1135
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
310
num At Risk
1126
group Id
EG001
num Affected
328
num At Risk
1145
group Id
EG002
num Affected
314
num At Risk
1135
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
252
num At Risk
1126
group Id
EG001
num Affected
234
num At Risk
1145
group Id
EG002
num Affected
204
num At Risk
1135
term
Neuropathy peripheral

Complete source fields

event Groups

description
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
id
EG000
other Num Affected
1112
other Num At Risk
1126
serious Num Affected
226
serious Num At Risk
1126
title
FOLFOX4
description
Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
id
EG001
other Num Affected
1127
other Num At Risk
1145
serious Num Affected
297
serious Num At Risk
1145
title
FOLFOX4 + Bv
description
Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
id
EG002
other Num Affected
1117
other Num At Risk
1135
serious Num Affected
284
serious Num At Risk
1135
title
XELOX+Bv

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
725
num At Risk
1126
group Id
EG001
num Affected
761
num At Risk
1145
group Id
EG002
num Affected
720
num At Risk
1135
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
620
num At Risk
1126
group Id
EG001
num Affected
699
num At Risk
1145
group Id
EG002
num Affected
699
num At Risk
1135
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
385
num At Risk
1126
group Id
EG001
num Affected
394
num At Risk
1145
group Id
EG002
num Affected
460
num At Risk
1135
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
310
num At Risk
1126
group Id
EG001
num Affected
360
num At Risk
1145
group Id
EG002
num Affected
246
num At Risk
1135
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
308
num At Risk
1126
group Id
EG001
num Affected
324
num At Risk
1145
group Id
EG002
num Affected
219
num At Risk
1135
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
220
num At Risk
1126
group Id
EG001
num Affected
227
num At Risk
1145
group Id
EG002
num Affected
214
num At Risk
1135
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
126
num At Risk
1126
group Id
EG001
num Affected
162
num At Risk
1145
group Id
EG002
num Affected
84
num At Risk
1135
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
86
num At Risk
1126
group Id
EG001
num Affected
118
num At Risk
1145
group Id
EG002
num Affected
113
num At Risk
1135
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
29
num At Risk
1126
group Id
EG001
num Affected
68
num At Risk
1145
group Id
EG002
num Affected
41
num At Risk
1135
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
430
num At Risk
1126
group Id
EG001
num Affected
430
num At Risk
1145
group Id
EG002
num Affected
436
num At Risk
1135
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
310
num At Risk
1126
group Id
EG001
num Affected
328
num At Risk
1145
group Id
EG002
num Affected
314
num At Risk
1135
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
252
num At Risk
1126
group Id
EG001
num Affected
234
num At Risk
1145
group Id
EG002
num Affected
204
num At Risk
1135
term
Neuropathy peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
28
num At Risk
1126
group Id
EG001
num Affected
28
num At Risk
1145
group Id
EG002
num Affected
62
num At Risk
1135
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
11
num At Risk
1126
group Id
EG001
num Affected
14
num At Risk
1145
group Id
EG002
num Affected
18
num At Risk
1135
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
1126
group Id
EG001
num Affected
11
num At Risk
1145
group Id
EG002
num Affected
16
num At Risk
1135
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
6
num At Risk
1126
group Id
EG001
num Affected
9
num At Risk
1145
group Id
EG002
num Affected
7
num At Risk
1135
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
7
num At Risk
1135
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
7
num At Risk
1145
group Id
EG002
num Affected
3
num At Risk
1135
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
3
num At Risk
1126
group Id
EG001
num Affected
0
num At Risk
1145
group Id
EG002
num Affected
5
num At Risk
1135
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
1126
group Id
EG001
num Affected
2
num At Risk
1145
group Id
EG002
num Affected
4
num At Risk
1135
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
1126
group Id
EG001
num Affected
4
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
1126
group Id
EG001
num Affected
1
num At Risk
1145
group Id
EG002
num Affected
5
num At Risk
1135
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
1126
group Id
EG001
num Affected
0
num At Risk
1145
group Id
EG002
num Affected
2
num At Risk
1135
term
Abdominal adhesions

time Frame

All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.

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