Table 2.
Pooled Incidence of Treatment-Related Adverse Events For Complex Skin and Skin Structure Infections
| Adverse Event |
Ceftobiprole (n= 932) |
Comparator Drug* (n= 661) |
|---|---|---|
| No. (%) | No. (%) | |
| Nausea | 113 (12) | 49 (7) |
| Vomiting | 61 (7) | 27 (4) |
| Diarrhea | 62 (7) | 32 (5) |
| Constipation | 33 (4) | 25 (4) |
| Dysgeusia† | 30 (3) | 2 (1) |
| Headache | 68 (7) | 39 (6) |
| Dizziness† | 14 (4) | 8 (2) |
| Insomnia‡ | 26 (5) | 13 (5) |
| Infusion-site reaction† | 48 (9) | 26 (9) |
| Hypersensitivity§ | 49 (5) | 62 (9) |
| Overall adverse drug events | ||
| • One or more adverse drug events | 507 (54) | 352 (53) |
| • One or more serious adverse drug events | 63 (7) | 47 (7) |
| • Discontinued therapy because of adverse drug events | 39 (4) | 32 (5) |
*
Comparator regimen: vancomycin (STRAUSS 1); vancomycin plus ceftazidime (STRAUSS 2).
†
Data reported for STRAUSS 1 only.
‡
Data reported for STRAUSS 2 only.
§
Data for STRAUSS 1 is a combination of rash and pruritus. The overall incidence of hypersensitivity was not reported in this trial.