Safety
Adverse events (AEs) are summarized in Table 4. A total 71 AEs occurred
in 35 out of 60 (58.3%) patients included in the FAS. The distributions
of AEs in the expressor and non-expressor groups did not differ
significantly (P=0.796). Most AEs, 82.9% in the expressor group and
63.3% in the non-expressor group, were mild. However, the incidence of
moderate severity AEs in the expressor group was lower than in the
non-expressor group (14.6% vs. 33.3%). In the expressor group, 24.4%
of the AEs had a probable or possible relationship to the study drug,
and three patients experienced AEs that led to drug discontinuation. No
AEs related to the study drug or requiring its discontinuation were
recorded in the non-expressor group. While the incidence of AEs in the
investigations and gastrointestinal systems was higher in the expressor
group than in the non-expressor group, the study groups did not differ
significantly in the incidence of AEs involving the other organ systems
(Figure 5). Serious AEs involving the nervous system (n = 1),
investigations (n = 2), and gastrointestinal system (n = 3) occurred
solely in the expressor group. Additionally, severe infectious
complications were not developed in the patients.