Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

Table. 2.

Adverse Drug Reactions

Event Total ≥ 65 yr ≥ 75 yr
Safety analysis population 1049 763 531
Patients with ADRs 55 (5.24) 34 (4.46) 19 (3.58)
Gastrointestinal disorders 52 (4.96) 31 (4.06) 16 (3.01)
Diarrhea 23 (2.19) 16 (2.10) 7 (1.32)
Abdominal pain 19 (1.81) 11 (1.44) 5 (0.94)
Abdominal distension 4 (0.38) 2 (0.26) 2 (0.38)
Nausea 3 (0.29) 1 (0.13) 1 (0.19)
Abdominal discomfort 2 (0.19) 0 (0.00) 0 (0.00)
Constipation 2 (0.19) 2 (0.26) 0 (0.00)
Eructation 1 (0.10) 0 (0.00) 0 (0.00)
Vomiting 1 (0.10) 1 (0.13) 1 (0.19)
Soft feces 1 (0.10) 1 (0.13) 1 (0.19)
Anal incontinence 1 (0.10) 1 (0.13) 1 (0.19)
Skin and subcutaneous tissue disorders 1 (0.10) 1 (0.13) 1 (0.19)
Rash 1 (0.10) 1 (0.13) 1 (0.19)
Nervous system disorders 1 (0.10) 1 (0.13) 1 (0.19)
Headache 1 (0.10) 1 (0.13) 1 (0.19)
General disorders and administration site conditions 1 (0.10) 1 (0.13) 1 (0.19)
Death 1 (0.10) 1 (0.13) 1 (0.19)

ADR, adverse drug reaction.

Data are presented as n (%) of patients who experienced each event.

J Neurogastroenterol Motil 2022;28:431~441 https://doi.org/10.5056/jnm20263
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