Expressor (n = 28) Non-expressor (n = 32)
P-value
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