Variable | Group 1 | Group 2 | Group 3 and 4 |
---|---|---|---|
ECG measurements | 12 | 12 | 24 |
QT prolongation events | 0 | 0 | 0 |
Grade 1 (mild) | 0 | 0 | 0 |
Grade 2 (moderate) | 0 | 0 | 0 |
Grade 3 (severe) | 0 | 0 | 0 |
Maximum △QTcF (ms) | 7.7 (5.8, 15) | 14.1 (11.5, 20.2) | 7.3 (− 7.6, 34) |
Events with DQTcF > 30 ms < 60 ms | 0 | 0 | 1 |
Events with DQTcF ≥ 60 ms | 0 | 0 | 0 |
Maximum QTcF (ms) | 383.9 (379.5, 403.6) | 403.5 (400.7, 427.9) | 413.1 (388.5, 420.1) |
Time after dose at maximum QTcF (days) | 7.9 (4.2, 27.9) | 7.7 (7.7, 26.9) | 28.9 (4.4, 29.1) |