Table 4.
Summary of treatment-emergent AEs (CE population)
| Number of patients with ≥ 1, n (%) |
All patients | High-risk | ||||||
|---|---|---|---|---|---|---|---|---|
| CAP | HAP (excluding VAP) | CAP | HAP (excluding VAP) | |||||
| Ceftobiprole (n = 231) |
Ceftriaxone ± linezolid (n = 238) |
Ceftobiprole (n = 198) |
Ceftazidime plus linezolid (n = 185) | Ceftobiprole (n = 193) |
Ceftriaxone ± linezolid (n = 205) |
Ceftobiprole (n = 169) |
Ceftazidime plus linezolid (n = 138) | |
| AE | 163 (70.6) | 149 (62.6) | 141 (71.2) | 140 (75.7) | 138 (71.5) | 133 (64.9) | 126 (74.6) | 112 (81.2) |
| SAE | 23 (10.0) | 24 (10.1) | 53 (26.8) | 39 (21.1) | 21 (10.9) | 22 (10.7) | 51 (30.2) | 33 (23.9) |
| Treatment-related AE | 82 (35.5) | 61 (25.6) | 51 (25.8) | 49 (26.5) | 70 (36.3) | 57 (27.8) | 46 (27.2) | 43 (31.2) |
| Treatment-related SAE | 2 (0.9) | 3 (1.3) | 7 (3.5) | 3 (1.6) | 2 (1.0) | 2 (1.0) | 7 (4.1) | 3 (2.2) |
| SAE leading to death | 3 (1.3) | 6 (2.5) | 27 (13.6) | 28 (15.1) | 3 (1.6) | 6 (2.9) | 26 (15.4) | 25 (18.1) |
AE adverse event, CAP community-acquired pneumonia, CE clinically evaluable, HAP hospital-acquired pneumonia, SAE serious adverse event, VAP ventilator-associated pneumonia