NCT01183780 · ADVERSE EVENTS

Adverse events

A Study in Second Line Metastatic Colorectal Cancer · Source last updated 2019-09-25

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: 5%

One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
FOLFIRI + Ramucirumab On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.	198 / 529	518 / 529	Not reported / Not reported
FOLFIRI + Placebo On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.	175 / 528	510 / 528	Not reported / Not reported

Group identifiers: EG000: FOLFIRI + Ramucirumab · EG001: FOLFIRI + Placebo

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 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
15
num At Risk
529
num Events
16
group Id
EG001
num Affected
8
num At Risk
528
num Events
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
6
num At Risk
529
num Events
7
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
2
num At Risk
528
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
2
num At Risk
528
num Events
2
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Cardio-respiratory arrest

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 17.1
stats
group Id
EG000
num Affected
93
num At Risk
529
num Events
225
group Id
EG001
num Affected
117
num At Risk
528
num Events
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
183
num At Risk
529
num Events
510
group Id
EG001
num Affected
131
num At Risk
528
num Events
259
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
80
num At Risk
529
num Events
177
group Id
EG001
num Affected
42
num At Risk
528
num Events
82
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
22
num At Risk
529
num Events
26
group Id
EG001
num Affected
27
num At Risk
528
num Events
29
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
124
num At Risk
529
num Events
178
group Id
EG001
num Affected
123
num At Risk
528
num Events
181
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
157
num At Risk
529
num Events
227
group Id
EG001
num Affected
132
num At Risk
528
num Events
196
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
315
num At Risk
529
num Events
881
group Id
EG001
num Affected
271
num At Risk
528
num Events
798
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
26
num At Risk
529
num Events
28
group Id
EG001
num Affected
27
num At Risk
528
num Events
32
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
27
num At Risk
529
num Events
33
group Id
EG001
num Affected
6
num At Risk
528
num Events
7
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
265
num At Risk
529
num Events
650
group Id
EG001
num Affected
274
num At Risk
528
num Events
715
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
27
num At Risk
529
num Events
35
group Id
EG001
num Affected
13
num At Risk
528
num Events
16
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
166
num At Risk
529
num Events
380
group Id
EG001
num Affected
113
num At Risk
528
num Events
235
term
Stomatitis

Complete source fields

description

event Groups

description
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
EG000
other Num Affected
518
other Num At Risk
529
serious Num Affected
198
serious Num At Risk
529
title
FOLFIRI + Ramucirumab
description
On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
EG001
other Num Affected
510
other Num At Risk
528
serious Num Affected
175
serious Num At Risk
528
title
FOLFIRI + Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
93
num At Risk
529
num Events
225
group Id
EG001
num Affected
117
num At Risk
528
num Events
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
183
num At Risk
529
num Events
510
group Id
EG001
num Affected
131
num At Risk
528
num Events
259
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
80
num At Risk
529
num Events
177
group Id
EG001
num Affected
42
num At Risk
528
num Events
82
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
22
num At Risk
529
num Events
26
group Id
EG001
num Affected
27
num At Risk
528
num Events
29
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
124
num At Risk
529
num Events
178
group Id
EG001
num Affected
123
num At Risk
528
num Events
181
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
157
num At Risk
529
num Events
227
group Id
EG001
num Affected
132
num At Risk
528
num Events
196
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
315
num At Risk
529
num Events
881
group Id
EG001
num Affected
271
num At Risk
528
num Events
798
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
26
num At Risk
529
num Events
28
group Id
EG001
num Affected
27
num At Risk
528
num Events
32
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
27
num At Risk
529
num Events
33
group Id
EG001
num Affected
6
num At Risk
528
num Events
7
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
265
num At Risk
529
num Events
650
group Id
EG001
num Affected
274
num At Risk
528
num Events
715
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
27
num At Risk
529
num Events
35
group Id
EG001
num Affected
13
num At Risk
528
num Events
16
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
166
num At Risk
529
num Events
380
group Id
EG001
num Affected
113
num At Risk
528
num Events
235
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
15
num At Risk
529
num Events
16
group Id
EG001
num Affected
8
num At Risk
528
num Events
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
6
num At Risk
529
num Events
7
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
2
num At Risk
528
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
0
num At Risk
528
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
2
num At Risk
528
num Events
2
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
528
num Events
1
term
Cardio-respiratory arrest

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