NCT00561470 · ADVERSE EVENTS

Adverse events

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

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: From treatment initiation to 7 February, 2011
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo/FOLFIRI Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	198 / 605	575 / 605	Not reported / Not reported
Aflibercept/FOLFIRI Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	294 / 611	599 / 611	Not reported / Not reported

Group identifiers: EG000: Placebo/FOLFIRI · EG001: Aflibercept/FOLFIRI

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
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
3
num At Risk
605
group Id
EG001
num Affected
8
num At Risk
611
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
605
group Id
EG001
num Affected
11
num At Risk
611
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
605
group Id
EG001
num Affected
5
num At Risk
611
term
Device related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
605
group Id
EG001
num Affected
0
num At Risk
611
term
Cystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Oral candidiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
605
group Id
EG001
num Affected
4
num At Risk
611
term
Neutropenic infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
605
group Id
EG001
num Affected
0
num At Risk
611
term
Viral infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Pharyngitis

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
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
35
num At Risk
605
group Id
EG001
num Affected
51
num At Risk
611
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
202
num At Risk
605
group Id
EG001
num Affected
229
num At Risk
611
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
143
num At Risk
605
group Id
EG001
num Affected
195
num At Risk
611
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
12
num At Risk
605
group Id
EG001
num Affected
33
num At Risk
611
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
45
num At Risk
605
group Id
EG001
num Affected
47
num At Risk
611
term
Insomnia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
53
num At Risk
605
group Id
EG001
num Affected
136
num At Risk
611
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
53
num At Risk
605
group Id
EG001
num Affected
36
num At Risk
611
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
32
num At Risk
605
group Id
EG001
num Affected
42
num At Risk
611
term
Dysgeusia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
30
num At Risk
605
group Id
EG001
num Affected
34
num At Risk
611
term
Neuropathy peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
28
num At Risk
605
group Id
EG001
num Affected
33
num At Risk
611
term
Lethargy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
65
num At Risk
605
group Id
EG001
num Affected
250
num At Risk
611
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
45
num At Risk
605
group Id
EG001
num Affected
168
num At Risk
611
term
Epistaxis

Complete source fields

event Groups

description
Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
id
EG000
other Num Affected
575
other Num At Risk
605
serious Num Affected
198
serious Num At Risk
605
title
Placebo/FOLFIRI
description
Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
id
EG001
other Num Affected
599
other Num At Risk
611
serious Num Affected
294
serious Num At Risk
611
title
Aflibercept/FOLFIRI

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
35
num At Risk
605
group Id
EG001
num Affected
51
num At Risk
611
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
202
num At Risk
605
group Id
EG001
num Affected
229
num At Risk
611
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
143
num At Risk
605
group Id
EG001
num Affected
195
num At Risk
611
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
12
num At Risk
605
group Id
EG001
num Affected
33
num At Risk
611
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
45
num At Risk
605
group Id
EG001
num Affected
47
num At Risk
611
term
Insomnia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
53
num At Risk
605
group Id
EG001
num Affected
136
num At Risk
611
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
53
num At Risk
605
group Id
EG001
num Affected
36
num At Risk
611
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
32
num At Risk
605
group Id
EG001
num Affected
42
num At Risk
611
term
Dysgeusia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
30
num At Risk
605
group Id
EG001
num Affected
34
num At Risk
611
term
Neuropathy peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
28
num At Risk
605
group Id
EG001
num Affected
33
num At Risk
611
term
Lethargy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
65
num At Risk
605
group Id
EG001
num Affected
250
num At Risk
611
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
45
num At Risk
605
group Id
EG001
num Affected
168
num At Risk
611
term
Epistaxis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
3
num At Risk
605
group Id
EG001
num Affected
8
num At Risk
611
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
605
group Id
EG001
num Affected
11
num At Risk
611
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
605
group Id
EG001
num Affected
5
num At Risk
611
term
Device related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
605
group Id
EG001
num Affected
0
num At Risk
611
term
Cystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Oral candidiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
605
group Id
EG001
num Affected
4
num At Risk
611
term
Neutropenic infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
605
group Id
EG001
num Affected
0
num At Risk
611
term
Viral infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
0
num At Risk
605
group Id
EG001
num Affected
1
num At Risk
611
term
Pharyngitis

time Frame

From treatment initiation to 7 February, 2011

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Preserved source evidence · Not medical advice