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Table 4 Drug-related adverse events (n = 58) for safety population (n = 32)

From: Treatment of unresectable stage IV metastatic melanoma with aviscumine after anti-neoplastic treatment failure: a phase II, multi-centre study

Adverse effect Grade  
1 n (%) 2 3 4 Total
n (%) n (%) n (%) n (%) n (%)
Application site erythema 2 (6.3) 1 (3.1) - - 3 (9.4)
Application site pain 1 (3.1) 1 (3.1) - - 2 (6.3)
Application site pruritus 1 (3.1) 1 (3.1) - - 2 (6.3)
Application site rash 1 (3.1) - - - 1 (3.1)
Application site reaction 9 (28.1) 5 (15.6) - - 14 (43.8)
Application site swelling 1 (3.1)     1 (3.1)
Cerebral ischaemia - - - 1 (3.1) 1 (3.1)
Chills 1 (3.1) - - - 1 (3.1)
Decreased appetite - 1 (3.1) - - 1 (3.1)
Diarrhoea 1 (3.1) - - - 1 (3.1)
Dizziness 1 (3.1) - - - 1 (3.1)
Drug eruption 1 (3.1) 1 (3.1) - - 2 (6.3)
Dry mouth 1 (3.1) - - - 1 (3.1)
Dyspnoea - - - 1 (3.1) 1 (3.1)
Erythema 1 (3.1) - - - 1 (3.1)
Fatigue 3 (9.4) - - - 3 (9.4)
Headache 1 (3.1) - - - 1 (3.1)
Hyperglycaemia - - 1 (3.1) - 1 (3.1)
Leukopenia - - - 1 (3.1) 1 (3.1)
Musculoskeletal discomfort 1 (3.1) - - - 1 (3.1)
Nasopharyngitis 1 (3.1) - - - 1 (3.1)
Nausea - 1 (3.1) - - 1 (3.1)
Neutropenia - - - 1 (3.1) 1 (3.1)
Night sweats 1 (3.1) - - - 1 (3.1)
Oedema peripheral - 1 (3.1) - - 1 (3.1)
Pruritus 4 (12.5) - 1 (3.1) - 5 (15.6)
Pyrexia 2 (6.3) - - - 2 (6.3)
Thrombocytopenia - - - 1 (3.1) 1 (3.1)
Venous thrombosis - - 1 (3.1) - 1 (3.1)
Vision blurred 1 (3.1) - - - 1 (3.1)
Vulvovaginal mycotic infection 1 (3.1) - - - 1 (3.1)
Weight decreased - 1 (3.1) - - 1 (3.1)
Weight increased 1 (3.1) - - - 1 (3.1)
  1. Terms are from MedDRA (version 14.0) preferred terms, and grades are Common Toxicity Criteria of the National Cancer Institute (version 3.0). The drug-related adverse events occurred in 24 of 32 treated patients.