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Table 3 Adverse events

From: 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)

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 reactiona 14 (14.1%) 0 (0.0%)
 Nail toxicityb 28 (28.3%) 6 (6.1%)
  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.
  2. aThis special event category included the preferred terms infusion related reaction and pyrexia.
  3. bThis special event category included the preferred terms nail toxicity and paronychia.