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. 2019 Mar 28;59(8):1110–1119. doi: 10.1002/jcph.1412

Table 5.

Adverse Events Experienced by All Subjects per Treatment Group, by MedDRA Preferred Term: Safety Analysis Set

Mild Hepatic Impairment (N = 8) Moderate Hepatic Impairment (N = 8) Severe Hepatic Impairment (N = 6) Normal Hepatic Function (N = 8)
SOC MedDRA PT e n (%) e n (%) e n (%) e n (%)
Total 4 1 (12.5) 1 1 (12.5) 0 0 0 0
Gastrointestinal disorders 3 1 (12.5) 0 0 0 0 0 0
Diarrhea 3 1 (12.5) 0 0 0 0 0 0
Investigations 0 0 1 1 (12.5) 0 0 0 0
Platelet count low 0 0 1 1 (12.5) 0 0 0 0
Nervous system disorders 1 1 (12.5) 0 0 0 0 0 0
Dizziness 1 1 (12.5) 0 0 0 0 0 0

e, number of times the adverse event occurred; MedDRA PT, Medical Dictionary for Regulatory Activities preferred term; N, number of subjects exposed; n, number of subjects that experienced the AE; SOC, system organ class.