Table 3.
(a) | |||||
---|---|---|---|---|---|
Parameters (unit) | Category | 1 mg N = 27 | 4 mg N = 24 | ||
n | (%) | n | (%) | ||
QTcF (msec) | |||||
Actual value | ≤ 450 | 18 | 66.7 | 13 | 54.2 |
> 450 to ≤ 480 | 4 | 14.8 | 6 | 25.0 | |
> 480 to ≤ 500 | 0 | 1 | 4.2 | ||
> 500 | 1 | 3.7 | 0 | ||
Change from baseline | ≤ 30 | 21 | 77.8 | 14 | 58.3 |
> 30 to ≤ 60 | 2 | 7.4 | 4 | 16.7 | |
> 60 | 0 | 0 |
(b) | |||||
---|---|---|---|---|---|
Parameters (unit) | Category | 8 mg N = 5 | 12 mg N = 4 | ||
n | (%) | n | (%) | ||
QTcF (msec) | |||||
Actual value | ≤ 450 | 4 | 80.0 | 3 | 75.0 |
> 450 to ≤ 480 | 0 | 0 | |||
> 480 to ≤ 500 | 0 | 0 | |||
> 500 | 0 | 0 | |||
Change from baseline | ≤ 30 | 4 | 80.0 | 3 | 75.0 |
> 30 to ≤ 60 | 0 | 0 | |||
> 60 | 0 | 0 |
QTcF Fridericia’s corrected QT