Table 4.
Summary of commonly observed treatment emergent AEs (≥3% in either of the arms).
| MedDRA preferred term | Amoxicillin/clavulanic acid (N = 236) |
Clindamycin (N = 235) |
|---|---|---|
| Total number of treatment emergent AEs | 243 | 236 |
| Subjects who experienced at least one AE | 123 (52.1%) | 124 (52.8%) |
| Abdominal discomfort | 11 (4.7%) | 7 (3.0%) |
| Alanine aminotransferase increased | 26 (11.0%) | 24 (10.2%) |
| Aspartate aminotransferase increased | 24 (10.2%) | 20 (8.5%) |
| Blood bilirubin increased | 12 (5.1%) | 13 (5.5%) |
| Diarrhoea | 19 (8.1%) | 28 (11.9%) |
| Dizziness | 18 (7.6%) | 14 (6.0%) |
| Headache | 8 (3.4%) | 14 (6.0%) |
| Increased appetite | 20 (8.5%) | 15 (6.4%) |
| Nausea | 7 (3.0%) | 4 (1.7%) |
| Somnolence | 19 (8.1%) | 17 (7.2%) |