Table 8.
Safety Evaluation Through Final Visit: Safety Population
| AE Category | Sulopenem (N = 695), n (%) |
Ertapenem (N = 697), n (%) |
|---|---|---|
| Any AE | 105 (15.1) | 114 (16.4) |
| Any drug-related AE | 42 (6.0) | 64 (9.2) |
| Any AE with an outcome of death | 2 (0.3) | 0 (0.0) |
| Any serious AE | 14 (2.0) | 6 (0.9) |
| Any AE leading to discontinuation of study drug | 3 (0.4) | 4 (0.6) |
| Any AE of severe intensity | 5 (0.7) | 5 (0.7) |
| AEs reported in ≥2% of patients in either treatment group by system organ class and preferred terma | ||
| Nervous system disorders | ||
| ȃHeadache | 21 (3.0) | 16 (2.3) |
| Gastrointestinal disorders | ||
| ȃDiarrhea | 19 (2.7) | 21 (3.0) |
Abbreviation: AE, adverse event.
Medical Dictionary for Regulatory Activities (version 16.1) classification. Patients with multiple AEs were counted once for each category or system organ class and/or preferred term. Patients with AEs in >1 category were counted once in each of those categories.