Table 5.

Adverse events that occurred in ≥5% of patients (placebo or Varithena 1%).

	Main study Single-blind		Open-label Period
	Placebo	Varithena 1%	Varithena 1%
	N = 38 n (%)	N = 39 n (%)	N = 34 n (%)
Any adverse event	22 (57.9)	36 (92.3)	22 (64.7)
Arthralgia	1 (2.6)	2 (5.1)	1 (2.9)
Chest discomfort	0	2 (5.1)	0
Contusion	2 (5.3)	10 (25.6)	3 (8.8)
Edema, peripheral	0	2 (5.1)	1 (2.9)
Groin pain	0	2 (5.1)	0
Headache	0	4 (10.3)	3 (8.8)
Hematoma evacuation	0	2 (5.1)	3 (8.8)
Access-site complication	1 (2.6)	3 (7.7)	0
Access-site hematoma	3 (7.9)	4 (10.3)	10 (29.4)
Limb discomfort	1 (2.6)	10 (25.6)	3 (8.8)
Musculoskeletal discomfort	0	2 (5.1)	2 (5.9)
Myalgia	0	4 (10.3)	1 (2.9)
Nasopharyngitis	1 (2.6)	2 (5.1)	1 (2.9)
Pain in extremity	1 (2.6)	6 (15.4)	2 (5.9)
Paresthesia	0	2 (5.1)	0
Pruritus	5 (13.2)	3 (7.7)	1 (2.9)
Rash	1 (2.6)	2 (5.1)	0
Skin irritation	3 (7.9)	2 (5.1)	0
Thrombectomy/retained coagulum	0	4 (10.3)	8 (23.5)

All venous thrombus AEs are reported in Table 6.