Table 6.
Number (%) of treatment-emergent AEs with incidence > 5% by body system – safety population
| System organ class | Study group (N = 51) | Control group (N = 48) | Total (N = 99) | |
|---|---|---|---|---|
| Gastrointestinal disorders | Abdominal distension | 3 (5.9%) | 4 (8.3%) | 7 (7.1%) |
| Nausea | 4 (7.8%) | 1 (2.1%) | 5 (5.1%) | |
| Vomiting | 4 (7.8%) | 1 (2.1%) | 5 (5.1%) | |
| General disorders and administration site conditions | Pyrexia | 24 (47.1%) | 28 (58.3%) | 52 (52.5%) |
| Infections and infestations | Wound infection | 3 (5.9%) | 1 (2.1%) | 4 (4.0%) |
| Injury, poisoning, and procedural complications | Wound complication | 40 (78.4%) | 33 (68.8%) | 73 (73.7%) |
| Investigations | ALT increased | 6 (11.8%) | 6 (12.5%) | 12 (12.1%) |
| AST increased | 5 (9.8%) | 6 (12.5%) | 11 (11.1%) | |
| CRP increased | 5 (9.8%) | 9 (18.8%) | 14 (14.1%) | |
| γGT increased | 10 (19.6%) | 11 (22.9%) | 21 (21.2%) | |
| White blood count increased | 2 (3.9%) | 7 (14.6%) | 9 (9.1%) | |
| Metabolism and nutrition disorders | Hypoalbuminemia | 5 (9.8%) | 2 (4.2%) | 7 (7.1) |
ALT: alanine aminotranferase; AST: aspartate aminotranferase; CRP: C-reactive protein; γGT: gamma-glutamyltransferase.