Patients with adverse events |
17 (60.7%) |
18 (56.3%) |
0.796 |
Adverse events |
41 |
30 |
|
Severity
Mild
Moderate
Severe
|
34 (82.9%)
6 (14.6%)
1 (2.4%)
|
19 (63.3%)
10 (33.3%)
1 (3.3%)
|
0.070
|
Related to the study drug
Certain
Probable/likely
Possible
Unlikely
Conditional, unclassified
Unassessable/unclassifiable
|
0 (0%)
5 (12.2%)
5 (12.2%)
30 (73.2%)
1 (2.4%)
0 (0%)
|
0 (0%)
0 (0%)
0 (0%)
30 (100%)
0 (0%)
0 (0%)
|
0.023
|
Subjects with adverse events leading to drug discontinuation |
3
(10.7%) |
0 (0%) |
0.096 |