Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: The ELSIE study

Table 5 Adverse events

Preferred term	Grade 3 or 4	Any grade
Any, n (%)	68 (55.3)	123 (100)
Diarrhea	17 (13.8)	71 (57.7)
Neutropenia	11 (8.9)	30 (24.4)
Rash	7 (5.7)	70 (56.9)
Vomiting	7 (5.7)	48 (39.0)
Abdominal pain	4 (3.3)	22 (17.9)
Anemia	4 (3.3)	12 (9.8)
Fatigue	4 (3.3)	21 (17.1)
Febrile neutropenia	4 (3.3)	4 (3.3)
Nausea	4 (3.3)	55 (44.7)
Blood alkaline phosphatase increased	3 (2.4)	9 (7.3)
Dehydration	3 (2.4)	4 (0.3)
Hypersensitivity	3 (2.4)	9 (7.3)
Infection	3 (2.4)	4 (3.3)
Neutrophil count	3 (2.4)	3 (2.4)
Paronychia	3 (2.4)	16 (13.0)
White blood cell count decreased	3 (2.4)	7 (5.7)
Anorexia	2 (1.6)	35 (28.5)
Constipation	2 (1.6)	27 (22.0)
Stomatitis	1 (0.8)	26 (21.1)
Composite AE categories1
Infusion-related reactions2	3 (2.4)	19 (15.4)
Acne-like rash3	10 (8.1)	99 (80.5)

Grade 3/4 AEs (Adverse events) in > 2% and any grade AEs in > 20% of patients in the intention-to-treat/safety population and composite AE categories of special interest.

¹Composite categories where several Medical Dictionary for Regulatory Activities preferred terms have been pooled;

²Terms included acute myocardial infarction, acute respiratory failure, anaphylactic reaction, ^*anaphylactic shock, ^*anaphylactoid reaction, ^*anaphylactoid shock, ^*angina pectoris, apnea, asthma, blood pressure decreased, bronchial obstruction, bronchospasm, cardiac failure, cardiopulmonary failure, chills, clonus, convulsion, cyanosis, drug hypersensitivity, ^*dyspnea, dyspnea at rest, dyspnea exacerbated, dyspnea exertional, epilepsy, hyperpyrexia, hypersensitivity, ^*hypotension, hypoxia, infusion-related reaction, loss of consciousness, myocardial infarction, myocardial ischemia, orthopnea, pyrexia, respiratory distress, respiratory failure, shock, sudden death, and syncope;

³Terms included acne, acne pustular, dermatitis acneiform, dry skin, erythema, folliculitis, pruritus, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, skin exfoliation, skin hyperpigmentation, telangiectasia, and xerosis; ^*Preferred terms included in the infusion-related reactions category regardless of when they occurred; all other preferred terms in this category were included only if the onset date of the AE was on the day of the first cetuximab administration.