Table 1 Incidence of adverse events (intent-to-treat (ITT)/safety population).
| Â | Moxifloxacin (N = 569) n (%) | Placebo (N = 580) n (%) | p-value* |
|---|---|---|---|
Any adverse event | 467 (82.1) | 493 (85.0) | 0.181 |
Any treatment-emergent a adverse event | 258 (45.3) | 265 (45.7) | 0.906 |
Any treatment-emergent a drug-related adverse events b | 53 (9.3) | 22 (3.8) | < 0.001 |
   Cardiac disorders | 3 (0.5) | 1 (0.2) |  |
   Gastrointestinal disorders | 27 (4.7) | 4 (0.7) |  |
Diarrhea | 17 (3.0) | 9 (1.6) | Â |
Nausea | 6 (1.1) | 0 (-) | Â |
Vomiting | 5 (0.9) | 1 (0.2) | Â |
   General disorders and administration site conditions | 4 (0.7) | 2 (0.3) |  |
Asthenia | 3 (0.5) | 0 (-) | Â |
   Immune system disorders | 4 (0.7) | 0 (-) |  |
Hypersensitivity | 3 (0.5) | 0 (-) | Â |
   Infections and infestations | 5 (0.9) | 3 (0.5) |  |
   Musculoskeletal and connective tissue disorders | 3 (0.5) | 1 (0.2) |  |
   Nervous system disorders | 6 (1.1) | 4 (0.7) |  |
Dizziness | 3 (0.5) | 1 (0.2) | Â |
   Respiratory, thoracic and mediastinal disorders | 8 (1.4) | 0 (-) |  |
Dyspnea | 4 (0.7) | 0 (-) | Â |
   Skin and subcutaneous tissue disorders | 5 (0.9) | 5 (0.9) |  |
   Deaths | 15 (2.6) | 17 (2.9) |  |
Any treatment-emergent a serious adverse event | 94 (16.5) | 97 (16.7) | 0.926 |
Any treatment-emergent a drug-related serious adverse event | 9 (1.6) | 3 (0.3) | 0.076 |
Any adverse event leading to premature discontinuation | 26 (4.6) | 16 (2.8) | 0.102 |
Any deaths | 19 (3.3) | 26 (4.5) | 0.318 |