Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study

Table 2 Overview of TEAEs, treatment-related TEAEs, and serious TEAEs

	Patients experiencing any TEAE, n (%)
	Placebo (n = 38)	FBX IR 40 mg (n = 37)	FBX XR 40 mg (n = 39)	FBX IR 80 mg (n = 37)	FBX XR 80 mg (n = 38)
Overall TEAEs	13 (34.2)	16 (43.2)	16 (41.0)	11 (29.7)	13 (34.2)
Related to treatment	2 (5.3)	4 (10.8)	2 (5.1)	1 (2.7)	2 (5.3)
Not related to treatment	11 (28.9)	12 (32.4)	14 (35.9)	10 (27.0)	11 (28.9)
TEAEs by severity
Mild	7 (18.4)	8 (21.6)	9 (23.1)	6 (16.2)	4 (10.5)
Moderate	6 (15.8)	7 (18.9)	6 (15.4)	5 (13.5)	7 (18.4)
Severe	0	1 (2.7)	1 (2.6)	0	2 (5.3)
TEAEs leading to study drug discontinuation	2 (5.3)	0	1 (2.6)	1 (2.7)	0
Serious TEAEs	0	1 (2.7)	1 (2.6)	0	4 (10.5)
Related to treatment	0	0	0	0	0
Not related to treatment^a	0	1 (2.7)	1 (2.6)	0	4 (10.5)
Leading to study drug discontinuation	0	0	0	0	0
Deaths	0	0	0	0	1 (2.6)

Safety analysis set. ^aSerious TEAEs reported in each of the treatment groups: FBX IR 40 mg, one patient had both gastroenteritis and acute kidney injury; FBX XR 40 mg, one patient had cholelithiasis; FBX XR 80 mg, three patients had coronary artery disease, gangrene, or hypertension and one patient had both sinus node dysfunction and a fatal cardiac arrest
FBX febuxostat, IR immediate release, TEAE treatment-emergent adverse event, XR extended release

ISSN: 1478-6362