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.