TABLE 3.
QTc interval by category between treatment arms
| QTc interval | No. of subjects with the indicated characteristic after the 1st dose |
P value | No. of subjects with the indicated characteristic after the 2nd dose |
P value | ||
|---|---|---|---|---|---|---|
| DP (n = 47) | Placebo (n = 22) | DP (n = 46) | Placebo (n = 22) | |||
| QTc prolongation | ||||||
| QTcFe | ||||||
| <450 ms | 33 | 22 | 0.003 | 20 | 22 | <0.0001 |
| 450–479 ms | 12 | 0 | 20 | 0 | ||
| 480–499 ms | 1 | 0 | 3 | 0 | ||
| ≥500 ms | 1 | 0 | 3 | 0 | ||
| QTcFm | ||||||
| <450 ms | 38 | 22 | 0.0489 | 28 | 22 | 0.0003 |
| 450–479 ms | 8 | 0 | 14 | |||
| 480–499 ms | 0 | 0 | 4 | |||
| ≥500 ms | 1 | 0 | 0 | |||
| Change of QTc over baseline | ||||||
| QTcFe | ||||||
| <30 ms | 29 | 22 | 0.0003 | 11 | 22 | <0.0001 |
| 30–59 ms | 16 | 0 | 28 | 0 | ||
| ≥60 ms | 2 | 0 | 7 | 0 | ||
| QTcFm | ||||||
| <30 ms | 22 | 19 | 0.0018 | 14 | 19 | <0.0001 |
| 30–59 ms | 13 | 3 | 14 | 3 | ||
| ≥60 ms | 12 | 0 | 18 | 0 | ||