Table 5.
Summary of AEs affecting either treatment group: safety population
| Summary of AE, n (%) | Treatment group |
|
|---|---|---|
| delafloxacin, N = 324 | vancomycin + aztreonam, N = 326 | |
| Overall TEAEs | 154 (47.5) | 193 (59.2) |
| TEAEs affecting ≥5% of patients | ||
| diarrhoea | 27 (8.3) | 10 (3.1) |
| headache | 10 (3.1) | 25 (7.7) |
| infection | 28 (8.6) | 25 (7.7) |
| infusion-site extravasation | 28 (8.6) | 44 (13.5) |
| nausea | 24 (7.4) | 28 (8.6) |
| TEAEs by intensity | ||
| mild | 90 (27.8) | 126 (38.7) |
| moderate | 53 (16.4) | 60 (18.4) |
| severe | 11 (3.4) | 7 (2.1) |
| TEAEs related to study drug | ||
| total related to study drug | 78 (24.1) | 107 (32.8) |
| possibly | 56 (17.3) | 75 (23.0) |
| probably | 14 (4.3) | 23 (7.1) |
| definitely | 8 (2.5) | 9 (2.8) |
| TEAEs leading to early discontinuation of study drug | 3 (0.9) | 14 (4.3) |
| Related TEAEs leading to early discontinuation of study drug | 1 (0.3) | 8 (2.5) |
| Overall serious AEs | 12 (3.7) | 12 (3.7) |
| Deaths | 1 (0.3) | 1 (0.3) |