Table 4.

Summary of Treatment‐Emergent Adverse Events With Single‐Dose Intravenous Oliceridine in Healthy Subjects and Subjects With End‐Stage Renal Disease or Hepatic Impairment

Renal Impairment Study
	ESRD	Healthy
Number of subjects in group	9	8
Oliceridine dose	0.5 mg	1 mg
Subjects with at least 1 TEAE, n (%), no. of events	2 (22%), 2	4 (50%), 9
Subjects with TEAEs by maximum severity
Mild	2 (22%), 2	4 (50%), 9
Moderate	0	0
Severe	0	0
Adverse event
Nausea	1 (11%), 1	2 (25%), 3
Fatigue	1 (11%), 1	2 (25%), 2
Feeling of relaxation	0	1 (12.5%), 1
Pain in extremity	0	1 (12.5%), 1
Dizziness	0	1 (12.5%), 1
Headache	0	1 (12.5%), 1
Euphoria	0	2 (25%), 2

Hepatic Impairment Study
	Mild	Moderate	Severe	Healthy
Number of subjects in group	10	10	6	8
Oliceridine dose	0.5 mg	0.5 mg	0.5 mg	1 mg
Subjects with at least 1 TEAE, n (%), no. of events	2 (20%), 2	0 (0%), 0	0 (0%), 0	0 (0%), 0
Subjects with TEAEs by maximum severity
Mild	2 (20%), 2	0 (0%), 0	0 (0%), 0	0 (0%), 0
Moderate	0	0	0	0
Severe	0	0	0	0
Adverse event
Somnolence	2 (20%), 2	0 (0%), 0	0 (0%), 0	0 (0%), 0

ESRD indicates end‐stage renal disease; TEAE, treatment‐emergent adverse event.