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. 2014 May 17;13:94. doi: 10.1186/1475-2840-13-94

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
 
  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.

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