Table 2.
Audencel toxicity assessment according to WHO guidelines.
| Toxicity | Control n = 42 | Audencel n = 34 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| WHO | II | % | III-IV | % | All Grades | II | % | III-IV | % | All Grades |
| Haematologic toxicity | ||||||||||
| Anemia | 0 | 0 | 0 | 0 | 0 | 3 | 8.2 | 0 | 0 | 3 |
| Leucopenia | 3 | 7.1 | 2 | 5 | 5 | 2 | 6 | 2 | 6 | 4 |
| Lymphopenia | 2 | 4.8 | 0 | 0 | 2 | 2 | 6 | 1 | 3 | 3 |
| Thrombopenia | 9 | 21 | 2 | 5 | 11 | 6 | 17 | 7 | 20.50 | 13 |
| Non-haematologic toxicity | ||||||||||
| Fatigue | 9 | 21 | 1 | 2 | 10 | 15 | 45 | 3 | 8 | 18 |
| Headache | 11 | 26 | 2 | 5 | 13 | 13 | 38 | 2 | 6 | 15 |
| Nausea | 7 | 17 | 0 | 0 | 7 | 13 | 38 | 1 | 3 | 14 |
| Vomiting | 4 | 9.5 | 0 | 0 | 4 | 4 | 12 | 0 | 0 | 4 |
| VTE event | 0 | 0 | 3 | 7 | 3 | 0 | 0 | 0 | 0 | 0 |
| Intracranial bleeding | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 2 | 5 | 2 |
| Influenza like illness | 1 | 2.4 | 0 | 0 | 1 | 3 | 8.2 | 0 | 0 | 3 |
| Fever | 2 | 4.8 | 0 | 0 | 2 | 7 | 21 | 0 | 0 | 7 |
| Vaccination site reaction | not relevant | |||||||||
| erythema | 6 | 18 | 0 | 0 | 6 | |||||
| pruritus | 6 | 18 | 0 | 0 | 6 | |||||
| Pain, induration | 6 | 18 | 0 | 0 | 6 |
VTE: venous thromboembolism.