ECG Parameters, | Visit code | Group 1 | Group 2 | Group 3 and 4 | ||||||
---|---|---|---|---|---|---|---|---|---|---|
n | Values | Change from baseline | n | Values | Change from baseline | n | Values | Change from baseline | ||
HR (Beats/min) | Baseline | 3 | 74 (72.1, 84.4) | – | 3 | 67 (60.4, 81.3) | – | 6 | 68.5 (57.4, 86.8) | – |
Day 3 | 3 | 79 (64.8, 82.8) | − 6.0 (− 9.8, 10.2) | 3 | 71 (67.2, 75.8) | 4.0 (− 5.5, 6.9) | 6 | 58.5 (53.4, 94.8) | − 5.5 (− 14.4, 15.8) | |
Day 7 | 3 | 78 (76.1, 87.5) | 2.0 (− 6.5, 15.3) | 3 | 65 (63.1, 72.6) | − 4.0 (− 8.8, 4.6) | 6 | 66.5 (57.1, 89.1) | − 0.5 (− 10.0, 8.8) | |
Day 28 | 3 | 67 (67, 67) | − 7.0 (− 17.4, − 5.1) | 3 | 73 (70.2, 75.9) | 6.0 (− 11.1, 15.5) | 6 | 66 (58.1, 73.5) | − 3.5 (− 14.1, 1.9) | |
Day 56 | 3 | 67 (65.1, 75.6) | − 9.0 (− 17.5, 3.4) | 3 | 67 (66, 80.3) | − 1.0 (− 1.0, 6.6) | 6 | 67 (58.1, 94.4) | 1.5 (− 9.2, 7.9) | |
QTc Fridericia (ms) | Baseline | 3 | 376.2 (364.5, 397.8) | – | 3 | 392.2 (380.6, 413.9) | – | 6 | 402.1 (357.1, 418.1) | – |
Day 3 | 3 | 379.2 (378.9, 393.6) | 2.7 (− 4.2, 14.7 | 3 | 395.6 (378.5, 406.3) | − 2.4 (− 7.9, 3.1) | 6 | 398.4 (366, 419.2) | − 2.3 (− 10.8, 10.4) | |
Day 7 | 3 | 377.2 (371.4, 403.3) | 5.7 (1.3, 7.1) | 3 | 402.5 (400.6, 427.8) | 14.1 (10.5, 20.2) | 6 | 393.2 (356.9, 414.2) | − 12.0 (− 21.7, 11.8) | |
Day 28 | 3 | 383.9 (370.1, 401.6) | 5.5 (3.7, 7.6) | 3 | 403.5 (355.3, 416.2) | 1.8 (− 25.8, 10.9) | 6 | 398.8 (388.5, 413.2) | − 5.7 (− 14.4, 33.7) | |
Day 56 | 3 | 383 (366.1, 403.6) | 5.7 (1.5, 6.8) | 3 | 392.3 (372.5, 420.7) | 0.1 (− 8.2, 6.8) | 6 | 398.3 (367.1, 404.5) | − 6.4 (− 14.3, 10.6) | |
QTc Bazett (ms) | Baseline | 3 | 389 (387.1, 411.8) | – | 3 | 400 (383.8, 437) | – | 6 | 413.5 (380.1, 426.2) | – |
Day 3 | 3 | 399 (397.1, 400) | 10 (− 12.8, 1) | 3 | 409 (388.1, 422.3) | 4 (− 15, 8.8) | 6 | 397.5 (389.2, 430.5) | − 10.5 (− 23.2, 18) | |
Day 7 | 3 | 403 (388.8, 420.1) | 8 (1.4, 13.7) | 3 | 407 (406, 442.1) | 6 (5.1, 23.1) | 6 | 401.5 (378.4, 431.1) | − 11 (− 30.4, 19) | |
Day 28 | 3 | 393 (378.8, 411) | − 1 (− 8.6, 3.8) | 3 | 417 (370.4, 428.4) | − 10 (− 14.8, 15.7) | 6 | 406.5 (395.8, 421.8) | − 3 (− 25.4, 25.8) | |
Day 56 | 3 | 400 (375.3, 410.4) | − 2 (− 12.4, 10.4) | 3 | 400 (380, 443.7) | 0 (− 3.8, 6.7) | 6 | 405 (390.5, 414.9) | − 8.5 (− 18.4, 15.9) |