Table 3.

Treatment-Related Treatment-Emergent Adverse Events for RT234 and Twenty Milligrams Oral Vardenafil in Healthy Volunteers

System organ class (preferred term)	RT234 (N = 31) N (%)	Oral vardenafil (N = 5) N (%)
Subjects with at least one TEAE	19 (61.3)	4 (80.0)
Nervous system disorders	12 (38.7)	4 (80.0)
Headache	10 (32.3)	4 (80.0)
Dizziness	4 (12.9)	4 (80.0)
Postural dizziness	1 (3.2)	0 (0.0)
Autonomic nervous system imbalance	1 (3.2)	1 (20.0)
Lethargy	1 (3.2)	0 (0.0)
Head discomfort	1 (3.2)	0 (0.0)
Eye disorders	2 (6.4)	2 (40.0)
Eye pain	1 (3.2)	1 (20.0)
Photophobia	2 (6.4)	0 (0.0)
Scleral hyperemia	0 (0.0)	1 (20.0)
Vascular disorders	1 (3.2)	1 (20.0)
Flushing	1 (3.2)	1 (20.0)
Gastrointestinal disorders	5 (9.7)	0 (0.0)
Nausea	3 (9.7)	0 (0.0)
Abdominal pain	2 (6.4)	0 (0.0)
Vomiting	1 (3.2)	0 (0.0)
Respiratory, thoracic, and mediastinal disorders	5 (16.1)	0 (0.0)
Cough	3 (9.7)	0 (0.0)
Nasal congestion	2 (6.4)	0 (0.0)
General disorders	1 (3.2)	1 (20.0)
Chills	1 (3.2)	1 (20.0)
Infections and infestations	1 (3.2)	0 (0.0)
URT infection	1 (3.2)	0 (0.0)
Reproductive system and breast disorders	1 (3.2)	0 (0.0)
Spontaneous penile erection	1 (3.2)	0 (0.0)

TEAE, treatment-emergent adverse event; URT, upper respiratory tract.