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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.