Table 2.
Analysis of outliers for QTcF in the phase I clinical study
| Parameter | Placebo (n = 39)a n (%) | Isavuconazole | Moxifloxacin (n = 40)a n (%) | |
|---|---|---|---|---|
| 200 mg (n = 37)a n (%) | 600 mg (n = 32)a n (%) | |||
| Extreme valuesb | ||||
| <360 msec | 1 (2.6) | 2 (5.4) | 5 (15.6) | 1 (2.5) |
| <330 msec | 0 | 0 | 0 | 0 |
| >450 msec | 0 | 0 | 0 | 5 (12.5) |
| >480 msec | 0 | 0 | 0 | 0 |
| Change from baselinec | ||||
| >30 msec increase | 3 (7.7) | 0 | 0 | 4 (10.0) |
| >60 msec increase | 0 | 0 | 0 | 0 |
| >30 msec decrease | 1 (2.6) | 7 (18.9) | 13 (40.6) | 1 (2.5) |
| >60 msec decrease | 0 | 0 | 0 | 0 |
QTcF, Fridericia‐corrected QT interval.
a
Number of subjects with a nonmissing value.
b
Using the average of the replicates at each timepoint.
c
Baseline defined as average of replicates at each time point from Day 1; postbaseline defined as average of replicates from Day 13; percentages calculated as the total number of subjects within the change from baseline category divided by the total number of subjects with a nonmissing value, at each timepoint.