Table 3 Serious adverse events
Serious adverse event, n (%) | Placebo (n = 68) | Vernakalant (n = 129) |
|---|---|---|
Any SAE | 4 (5.9) | 10 (7.8) |
Blood and lymphatic system disorders | ||
Coagulopathy | 0 | 1 (0.8) |
Iron-deficiency anaemia | 1 (1.5) | 0 |
Cardiac disorders | ||
Atrial fibrillation | 2 (2.9) | 6 (4.7) |
Atrial flutter | 0 | 2 (1.6) |
Cardiogenic shock | 0 | 1 (0.8) |
Sinus arrest | 0 | 1 (0.8) |
Gastrointestinal disorders | ||
Nausea | 0 | 1 (0.8) |
General disorders and administration site conditions | ||
Non-cardiac chest pain | 1 (1.5) | 0 |
Hepatic failure | 0 | 1 (0.8) |
Infections and infestations | ||
Sepsis | 0 | 1 (0.8) |
Musculoskeletal and connective tissue disorders | ||
Rhabdomyolysis | 0 | 1 (0.8) |
Nervous system disorders | ||
Headache | 0 | 1 (0.8) |
Psychiatric disorders | ||
Confusional state | 0 | 1 (0.8) |
Renal and urinary disorders | ||
Acute renal failure | 0 | 1 (0.8) |
Respiratory, thoracic and mediastinal disorders | ||
Pneumonia aspiration | 0 | 1 (0.8) |
Skin and subcutaneous tissue disorders | ||
Cold sweat | 0 | 1 (0.8) |