Table 6.
Adverse events
| AQUACEL® Ag/AQUACEL® (n = 145), N (%) | Urgotul® Silver/Urgotul® (n = 136), N (%) | |
|---|---|---|
| Summary of AEs | ||
| Subjects with events | 72 (49·7) | 57 (41·9) |
| Subjects with related AEs | 33 (22·8) | 24 (17·6) |
| Subjects with SAEs | 6 (4·1) | 6 (4·4) |
| Subjects with death | 0 | 2 (1·4) |
| Related SAEs | 0 | 0 |
| Discontinuations due to AEs | 9 (6·2) | 12 (8·8) |
| Incidence of AEs | ||
| Subjects with events | 72 (49·7) | 57 (41·9) |
| Skin and subcutaneous tissue disorder | 32 (22·1) | 40 (29·4) |
| Eczema | 9 (6·2) | 4 (2·9) |
| Venous ulcer pain | 9 (6·2) | 9 (6·6) |
| Skin ulcer | 8 (5·5) | 16 (11·8) |
| Erythema | 7 (4·8) | 12 (8·8) |
| Excessive granulation tissue | 2 (1·4) | 5 (3·7) |
| General disorders and administration site conditions | 31 (21·4) | 22 (16·2) |
| Deterioration of the wound | 13 (9·0) | 13 (9·6) |
| Pain | 11 (7·6) | 8 (5·9) |
| Oedema peripheral | 10 (6·9) | 6 (4·4) |
| Infections and infestations | 16 (11·0) | 12 (8·8) |
| Infected skin ulcer | 6 (4·1) | 4 (2·9) |
| Injury, poisoning and procedural complications | 21 (14·5) | 17 (12·5) |
| Wound secretion | 9 (6·2) | 6 (4·4) |
AE, adverse event; SAE, serious adverse events.