Safety and tolerability of canakinumab, an IL-1β inhibitor, in type 2 diabetes mellitus patients: a pooled analysis of three randomised double-blind studies

Table 3 Incidence of most common adverse events (occurring in at least five patients and in ≥2% in any group) by preferred term

Preferred term	Canakinumab pooled dose				Placebo
	Low dose	Intermediate dose	Medium dose	High dose	Placebo
	N = 20	N = 247	N = 268	N = 137	N = 354
Nasopharyngitis
n (%)	0	15 (6.1)	10 (3.7)	11 (8.0)	21 (5.9)
IR (%)		1.00	1.15	1.31	1.26
Bronchitis
n (%)	0	9 (3.6)	3 (1.1)	1 (0.7)	2 (0.6)
IR (%)		0.59	0.33	0.11	0.11
Urinary tract infection
n (%)	3 (15.0)	7 (2.8)	5 (1.9)	5 (3.6)	11 (3.1)
IR (%)	3.15	0.46	0.56	0.58	0.64
Upper respiratory tract infection
n (%)	0	6 (2.4)	3 (1.1)	4 (2.9)	4 (1.1)
IR (%)		0.39	0.33	0.47	0.23
Arthralgia
n (%)	0	5 (2.0)	3 (1.1)	3 (2.2)	7 (2.0)
IR (%)		0.32	0.33	0.35	0.41
Pain in extremity
n (%)	0	5 (2.0)	4 (1.5)	3 (2.2)	5 (1.4)
IR (%)		0.32	0.44	0.35	0.29
Headache
n (%)		4 (1.6)	2 (0.7)	5 (3.6)	8 (2.3)
IR (%)		0.26	0.22	0.58	0.47
Cough
n (%)		2 (0.8)	3 (1.1)	2 (1.5)	7 (2.0)
IR (%)		0.13	0.33	0.23	0.41
Oropharyngeal pain
n (%)		5 (2.0)	0	2 (1.5)	0
IR (%)		0.32		0.23

n (%) are expressed as number (%) of patients; incidence rate (IR) is expressed as % per month.
Low dose: 0.03 mg/kg i.v. once; intermediate dose: 0.1 and 0.3 mg/kg i.v. once, 5 and 15 mg s.c. monthly; medium dose: 1.5 mg/kg i.v. once, 50 mg s.c. monthly and 150 mg s.c. once; high dose: 10 mg/kg i.v. once and 150 mg s.c. monthly.

ISSN: 1475-2840