NCT01001377 · ADVERSE EVENTS

Adverse events

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer · Source last updated 2022-09-21

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: Median time was 117 days for panitumumab arm and 123 days for cetuximab arm.
Other-event reporting threshold: 5%

Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cetuximab Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.	169 / 503	474 / 503	Not reported / Not reported
Panitumumab Panitumumab 6 mg/kg IV every 14 days.	151 / 496	459 / 496	Not reported / Not reported

Group identifiers: EG000: Cetuximab · EG001: Panitumumab

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 15.1
stats
group Id
EG000
num Affected
3
num At Risk
503
group Id
EG001
num Affected
6
num At Risk
496
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiovascular insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
4
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Abdominal distension

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 15.1
stats
group Id
EG000
num Affected
30
num At Risk
503
group Id
EG001
num Affected
29
num At Risk
496
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
74
num At Risk
503
group Id
EG001
num Affected
52
num At Risk
496
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
70
num At Risk
503
group Id
EG001
num Affected
39
num At Risk
496
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
87
num At Risk
503
group Id
EG001
num Affected
88
num At Risk
496
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
26
num At Risk
503
group Id
EG001
num Affected
19
num At Risk
496
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
56
num At Risk
503
group Id
EG001
num Affected
66
num At Risk
496
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
34
num At Risk
503
group Id
EG001
num Affected
26
num At Risk
496
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
49
num At Risk
503
group Id
EG001
num Affected
49
num At Risk
496
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
44
num At Risk
503
group Id
EG001
num Affected
30
num At Risk
496
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
85
num At Risk
503
group Id
EG001
num Affected
72
num At Risk
496
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
38
num At Risk
503
group Id
EG001
num Affected
22
num At Risk
496
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
50
num At Risk
503
group Id
EG001
num Affected
28
num At Risk
496
term
Pyrexia

Complete source fields

description

event Groups

description
Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
id
EG000
other Num Affected
474
other Num At Risk
503
serious Num Affected
169
serious Num At Risk
503
title
Cetuximab
description
Panitumumab 6 mg/kg IV every 14 days.
id
EG001
other Num Affected
459
other Num At Risk
496
serious Num Affected
151
serious Num At Risk
496
title
Panitumumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
30
num At Risk
503
group Id
EG001
num Affected
29
num At Risk
496
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
74
num At Risk
503
group Id
EG001
num Affected
52
num At Risk
496
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
70
num At Risk
503
group Id
EG001
num Affected
39
num At Risk
496
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
87
num At Risk
503
group Id
EG001
num Affected
88
num At Risk
496
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
26
num At Risk
503
group Id
EG001
num Affected
19
num At Risk
496
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
56
num At Risk
503
group Id
EG001
num Affected
66
num At Risk
496
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
34
num At Risk
503
group Id
EG001
num Affected
26
num At Risk
496
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
49
num At Risk
503
group Id
EG001
num Affected
49
num At Risk
496
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
44
num At Risk
503
group Id
EG001
num Affected
30
num At Risk
496
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
85
num At Risk
503
group Id
EG001
num Affected
72
num At Risk
496
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
38
num At Risk
503
group Id
EG001
num Affected
22
num At Risk
496
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
50
num At Risk
503
group Id
EG001
num Affected
28
num At Risk
496
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
3
num At Risk
503
group Id
EG001
num Affected
6
num At Risk
496
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Cardiovascular insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
496
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
4
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
496
term
Abdominal distension

time Frame

Median time was 117 days for panitumumab arm and 123 days for cetuximab arm.

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