NCT01451632 · ADVERSE EVENTS

Adverse events

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers · Source last updated 2016-09-08

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: AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.
Other-event reporting threshold: 5%

All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: MM-121 + Cetuximab increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)	15 / 34	34 / 34	Not reported / Not reported
Part 2: MM-121 + Cetuximab + Irinotecan increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)	6 / 14	14 / 14	Not reported / Not reported

Group identifiers: EG000: Part 1: MM-121 + Cetuximab · EG001: Part 2: MM-121 + Cetuximab + Irinotecan

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
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Intestinal Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Disease Progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Mucosal Inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Abdominal Abscess

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
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
18
num At Risk
34
group Id
EG001
num Affected
4
num At Risk
14
term
Dermatitis Acneform
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
10
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Rash Maculopapular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
8
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
5
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Dry Skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
5
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Skin Fissures
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
4
num At Risk
34
group Id
EG001
num Affected
4
num At Risk
14
term
Palmar-Plantar Erythrodysaesthesia Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
3
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Skin Ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pruritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pruritis Generalized
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Pain of skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Nail Disorder

Complete source fields

description

event Groups

description
increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
id
EG000
other Num Affected
34
other Num At Risk
34
serious Num Affected
15
serious Num At Risk
34
title
Part 1: MM-121 + Cetuximab
description
increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
id
EG001
other Num Affected
14
other Num At Risk
14
serious Num Affected
6
serious Num At Risk
14
title
Part 2: MM-121 + Cetuximab + Irinotecan

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
18
num At Risk
34
group Id
EG001
num Affected
4
num At Risk
14
term
Dermatitis Acneform
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
10
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Rash Maculopapular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
8
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
5
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Dry Skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
5
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Skin Fissures
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
4
num At Risk
34
group Id
EG001
num Affected
4
num At Risk
14
term
Palmar-Plantar Erythrodysaesthesia Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
3
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Skin Ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pruritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pruritis Generalized
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
3
num At Risk
14
term
Pain of skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Any Relationship
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Nail Disorder

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
2
num At Risk
14
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Intestinal Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Disease Progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Mucosal Inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
0
num At Risk
34
group Id
EG001
num Affected
1
num At Risk
14
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
34
group Id
EG001
num Affected
0
num At Risk
14
term
Abdominal Abscess

time Frame

AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.

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