Drug-related adverse events (n = 58) for safety population (n = 32)
| 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) |
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.