NCT00265850 · ADVERSE EVENTS

Adverse events

Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer · Source last updated 2026-08-07

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: 0%

Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: FOLFOX or FOLFIRI + Bevacizumab Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.	98 / 559	531 / 559	Not reported / Not reported
Arm B: FOLFOX or FOLFIRI + Cetuximab Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.	111 / 578	548 / 578	Not reported / Not reported

Group identifiers: EG000: Arm A: FOLFOX or FOLFIRI + Bevacizumab · EG001: Arm B: FOLFOX or FOLFIRI + Cetuximab

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
2
num At Risk
578
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Eye disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
2
num At Risk
578
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
3
num At Risk
578
num Events
3
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Colonic perforation

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
4
num At Risk
578
num Events
4
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
559
num Events
5
group Id
EG001
num Affected
10
num At Risk
578
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
95
num At Risk
559
num Events
161
group Id
EG001
num Affected
83
num At Risk
578
num Events
145
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
7
num At Risk
559
num Events
7
group Id
EG001
num Affected
5
num At Risk
578
num Events
6
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
5
num At Risk
578
num Events
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
559
num Events
5
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
4
num At Risk
559
num Events
4
group Id
EG001
num Affected
5
num At Risk
578
num Events
5
term
Cardiac pain

Complete source fields

description

Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.

event Groups

description
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
id
EG000
other Num Affected
531
other Num At Risk
559
serious Num Affected
98
serious Num At Risk
559
title
Arm A: FOLFOX or FOLFIRI + Bevacizumab
description
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
id
EG001
other Num Affected
548
other Num At Risk
578
serious Num Affected
111
serious Num At Risk
578
title
Arm B: FOLFOX or FOLFIRI + Cetuximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
4
num At Risk
578
num Events
4
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
559
num Events
5
group Id
EG001
num Affected
10
num At Risk
578
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
95
num At Risk
559
num Events
161
group Id
EG001
num Affected
83
num At Risk
578
num Events
145
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
7
num At Risk
559
num Events
7
group Id
EG001
num Affected
5
num At Risk
578
num Events
6
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
5
num At Risk
578
num Events
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
559
num Events
5
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
4
num At Risk
559
num Events
4
group Id
EG001
num Affected
5
num At Risk
578
num Events
5
term
Cardiac pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
2
num At Risk
578
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Eye disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
2
num At Risk
578
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
559
num Events
1
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
1
num At Risk
578
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
0
num At Risk
559
num Events
0
group Id
EG001
num Affected
3
num At Risk
578
num Events
3
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
559
num Events
3
group Id
EG001
num Affected
0
num At Risk
578
num Events
0
term
Colonic perforation

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Preserved source evidence · Independent clinical review pending · Not medical advice