Table 2.
Adverse events in 2009 episodes during treatment and observation periods
| Event type | Number of events | Incidence (95% CI) | Considered drug-related, n (%) |
|---|---|---|---|
| All SAEs | 28 | 1.3% (0.8–1.9) | 22 (78.6) |
| Predefined SAEs | 19 | 0.8% (0.5–1.4) | 18 (94.7) |
| Significant hypotension | 2 | 0.1% (< 0.1–0.4) | 2 (100.0) |
| Bradycardiaα | 11 | 0.5% (0.3–10) | 10 (93.3) |
| Sinus arrest (> 3 s)β | 4 | 0.2% (< 0.1–0.4) | 4 (100.0) |
| Atrial flutter with 1: 1 AV conduction | 2 | 0.1% (0.1–0.4) | 2 (100.0) |
| Ventricular tachycardia γ | 0 | 0 | 0 (0.0) |
| Other than predefined SAEs | 9 | 0.45% | 5 (55.6) |
| Hypotension | 2 | 0.1% | 1 (50.0) |
| Supraventricular tachycardiaδ | 1 | < 0.1% | 1 (100.0) |
| Non-sustained ventricular tachycardiaε | 2 | < 0.1% | 1 (50.0) |
| Angina pectoris | 1 (< 0.1) | < 0.1% | 0 (0.0) |
| Pericardial effusion | 1 (< 0.1) | < 0.1% | 0 (0.0) |
| Visual disturbance | 1 (< 0.1) | < 0.1% | 0 (0.0) |
| Vernakalant overdoseζ | 1 (< 0.1) | < 0.1% | 1 (100.0) |
αNine cases of sinus bradycardia and 2 reported as significant bradycardia
βOne patient had both sinus arrest followed by sinus bradycardia
γOne event reclassified as atrial flutter with 1:1 conduction
δAtrial arrhythmia other than atrial flutter
εSee text, exceeding 5% of the weight-based dosing recommendation. In this case, the administered dose was 51% in excess of the recommended dose