Table 8.
Incidence of arrhythmic events (SAS)
| AE | PLA-DON10 | DON5-DON10 | DON10-DON10 | DON-DON10 a |
|---|---|---|---|---|
| ( n =37) | ( n =47) | ( n =49) | ( n =96) | |
| Subjects with any arrhythmic events, n (%) | 3 (8.1) | 4 (8.5) | 5 (10.2) | 9 (9.4) |
| Atrioventricular block | 0 | 0 | 2 (4.1) | 2 (2.1) |
| Palpitations | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Sinus bradycardia | 0 | 1 (2.1) | 1 (2.0) | 2 (2.1) |
| Supraventricular extrasystoles | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Ventricular extrasystoles | 0 | 0 | 1 (2.0) | 1 (1.0) |
| Electrocardiogram QT prolonged | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Loss of consciousness | 2 (5.4) | 0 | 1 (2.0) | 1 (1.0) |
| Syncope | 1 (2.7) | 0 | 0 | 0 |
SAS, safety analysis set; AE, adverse event.
aDON5-DON10 and DON10-DON10 groups.