Biweekly cetuximab in combination with FOLFOX-4 in the first-line treatment of wild-type KRASmetastatic colorectal cancer: final results of a phase II, open-label, clinical trial (OPTIMIX-ACROSS Study)

Table 3 Adverse events

Adverse event	Any grade	Grade 3 or 4
Any adverse event*	97 (98.0%)	77 (77.8%)
Blood and lymphatic system disorders
Anaemia	11 (11.1%)	2 (2.0%)
Febrile neutropenia	6 (6.1%)	5 (5.1%)
Leukopenia	15 (15.2%)	1 (1.0%)
Neutropenia	49 (49.5%)	32 (32.3%)
Thrombocytopenia	23 (23.2%)	2 (2.0%)
Gastrointestinal disorders
Abdominal pain	30 (30.3%)	2 (2.0%)
Diarrhoea	58 (58.6%)	13 (13.1%)
Intestinal obstruction	8 (8.1%)	8 (8.1%)
Nausea	28 (28.3%)	2 (2.0%)
Stomatitis	52 (52.5%)	5 (5.1%)
Vomiting	21 (21.2%)	1 (1.0%)
General disorders and administration site disorders
Asthenia	65 (65.7%)	8 (8.1%)
Immune system disorders
Drug hypersensitivity	9 (9.1%)	3 (3.0%)
Metabolism and nutrition disorders	37 (37.4%)	4 (4.0%)
Anorexia	25 (25.3%)	2 (2.0%)
Musculoskeletal and connective tissue disorders
Back pain	8 (8.1%)	2 (2.0%)
Nervous system disorders
Dysaesthesia	11 (11.1%)	2 (2.0%)
Dysgeusia	12 (12.1%)	1 (1.0%)
Peripheral neuropathy	11 (11.1%)	2 (2.0%)
Neurotoxicity	22 (22.2%)	2 (2.0%)
Paraesthesia	40 (40.4%)	6 (6.1%)
Psychiatric disorders
Anxiety	3 (3.0%)	2 (2.0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	3 (3.0%)	2 (2.0%)
Skin and subcutaneous tissue disorders
Dry skin	23 (23.2%)	4 (4.0%)
Vascular disorders
Deep vein thrombosis	3 (3.0%)	2 (2.0%)
Special adverse event categories
Acne-like Rash	91 (91.9%)	15 (15.2%)
Infusion related reaction^a	14 (14.1%)	0 (0.0%)
Nail toxicity^b	28 (28.3%)	6 (6.1%)

*Listed are adverse events of any grade occurring in at least 10% of patients and adverse events of grade 3 or 4 occurring in at least 2% of patient.
^aThis special event category included the preferred terms infusion related reaction and pyrexia.
^bThis special event category included the preferred terms nail toxicity and paronychia.

ISSN: 1471-2407