Observational Study
Copyright ©The Author(s) 2022.
World J Gastroenterol. Sep 14, 2022; 28(34): 5058-5075
Published online Sep 14, 2022. doi: 10.3748/wjg.v28.i34.5058
Table 5 Overview of adverse events–safety population

Events (n = 55)
Patients (n = 98)
All AEs5518 (18.4%)
Severe AEs10 (18.2%)5 (5.1%)
AEs related to study drug17 (30.9%)12 (12.2%)
Mild5 (29.4%)4 (4.1%)
Moderate6 (35.3%)6 (6.1%)
Severe4 (23.5%)2 (2.0%)
Not provided2 (11.8%)2 (2.0%)
Serious AEs27 (49.1%)7 (7.1%)
Number of patients with AEs
Resulting in hospitalization6 (6.1%)
Resulting in study drug discontinuation15 (15.3%)
Malignancy in patients ≤ 30 yr00
Death00