Number of Subjects with at least one treatment-emergent AE
|
74 (56.5%)
|
65 (51.2%)
|
0.393
|
Number of Subjects with a serious treatment-emergent AE
|
4 (3.1%)
|
4 (3.1%)
|
1.0002
|
Number of Subjects with at least one Related AE
|
40 (30.5%)
|
32 (25.2%)
|
0.339
|
Number of Subjects discontinuing study drug due to AE
|
6 (4.6%)
|
4 (3.1%)
|
0.7492
|
Number of deaths
|
0
|
0
|
_
|
Overall treatment0emergent AEs
| | | |
Number of Subjects with at least one Mild AE
|
62 (47.3%)
|
59 (46.5%)
|
0.221
|
Number of Subjects with at least one Moderate AE
|
5 (3.8%)
|
1 (0.8%)
|
0.2152
|
Number of Subjects with at least one Severe AE
|
7 (5.3%)
|
5 (3.9%)
|
0.711
|
Number of Subjects with Unrelated AE
|
34 (26.0%)
|
33 (26.0%)
|
0.570
|
Number of Subjects with at least one Possibly Related AE
|
24 (18.3%)
|
23 (18.1%)
|
0.714
|
Number of Subjects with at least one Probably Related AE
|
13 (9.9%)
|
8 (6.3%)
|
0.388
|
Number of Subjects with at least on Definitely Related AE
|
3 (2.3%
|
1 (0.8%)
|
0.6232
|