Table 7.

Summary of adverse events in the renal impairment study

Category, n (%)	Severe renal impairment (N=10)	Healthy control (N=10)	All subjects (N=20)
Any AE	7 (70.0)	5 (50.0)	12 (60.0)
Serious AE	0	0	0
AE leading to discontinuation	0	0	0
AE by highest severity
Mild	5 (50.0)	2 (20.0)	7 (35.0)
Moderate	2 (20.0)	1 (10.0)	3 (15.0)
Severe	0	2 (20.0)	2 (10.0)
AEs in ≥2 subjects in any cohort
Somnolence	2 (20.0)	3 (30.0)	5 (25.0)
Abdominal pain	2 (20.0)	1 (10.0)	3 (15.0)
Dizziness	2 (20.0)	1 (10.0)	3 (15.0)
Nausea	2 (20.0)	1 (10.0)	3 (15.0)
Lethargy	2 (20.0)	0	2 (10.0)

Abbreviation: AE, adverse event.