Table 4.
Safety Evaluation up to Late Follow-up (Safety Population)
| AE Category | Ceftazidime-Avibactam (n = 511) | Doripenem (n = 509) |
|---|---|---|
| Any AE | 185 (36.2) | 158 (31.0) |
| Any AE with an outcome of death | 0 | 0 |
| Any serious AE | 21 (4.1) | 12 (2.4) |
| Any AE leading to discontinuation of study drug | 7 (1.4) | 6 (1.2) |
| Any AE of severe intensity | 10 (2.0) | 7 (1.4) |
| AEs reported in ≥2% of patients in either treatment group by system organ class and preferred terma | ||
| Nervous system disorders | ||
| Headache | 38 (7.4) | 40 (7.9) |
| Gastrointestinal disorders | ||
| Nausea | 15 (2.9) | 10 (2.0) |
| Diarrhea | 14 (2.7) | 6 (1.2) |
| Constipation | 11 (2.2) | 7 (1.4) |
Data are presented as No. (%).
Abbreviation: AE, adverse event.
a MedDRA (version 16.1) classification. Patients with multiple AEs are counted once for each category or system organ class and/or preferred term. Patients with AEs in >1 category are counted once in each of those categories.