Table 5.
Statistical parameter | Median | Lower quartile | Upper quartile | ∆ vsD0 | p vsD0 | Median | Lower quartile | Upper quartile | ∆ vsD0 | p vsD0 |
---|---|---|---|---|---|---|---|---|---|---|
Variable | QTcB interval ms | Heart rate b/min | ||||||||
D0, pre-dose | 410 | 394 | 425 | 92 | 80 | 103 | ||||
D0 + 2 h | 412 | 398 | 428 | 2 | 0.3652 | 85 | 74 | 98 | −5 | 0.0012 |
D0 + 4 h | 416.5 | 397 | 429 | 3.5 | 0.2593 | 79 | 71 | 89 | −8.5 | <.0001 |
D2, pre-dose | 411 | 388 | 423 | −4.5 | 0.2551 | 59 | 53 | 64 | −35 | <.0001 |
D2 + 2 h | 415 | 393 | 433.5 | 3 | 0.4897 | 59.5 | 54 | 64.5 | −36 | <.0001 |
D2 + 4 h | 420 | 400 | 431 | 7.5† | 0.0059 | 59 | 55 | 65 | −31.5 | <.0001 |
D28 | 398 | 384 | 418 | −10.5 | 0.0016 | 66 | 59 | 74 | −25 | <.0001 |
Variable | QRS interval ms | PR interval ms | ||||||||
D0, pre-dose | 78 | 72 | 88 | 151.5 | 140.5 | 172.5 | ||||
D0 + 2 h | 82 | 72 | 89 | 2 | 0.2572 | 158 | 146 | 176 | 5 | 0.0061 |
D0 + 4 h | 82 | 76 | 88 | 1.5 | 0.1122 | 161 | 153 | 175 | 10 | <.0001 |
D2, pre-dose | 84 | 74 | 96 | 2.5 | 0.0084 | 163 | 154 | 185 | 12 | <.0001 |
D2 + 2 h | 85 | 79 | 95.5 | 6 | 0.0001 | 167 | 155.5 | 184.5 | 13.5 | <.0001 |
D2 + 4 h | 86 | 78 | 95 | 5 | 0.0003 | 172 | 151 | 187 | 15 | <.0001 |
D28 | 86 | 76 | 92 | 5.5 | 0.0073 | 164 | 147 | 179 | 12 | <.0001 |
*Only the QTcB data are normally distributed but the median interquartile ranges are shown for all parameters for clarity.
†Corresponding mean 95% confidence intervals are: 9.02 (2.72-15.31) ms.