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Table 2 Summary of adverse events reported in the pooled data

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

 

Canakinumab pooled dose

Placebo

Low dose

Intermediate dose

Medium dose

High dose

N = 20

N = 247

N = 268

N = 137

N = 354

Any AEs

n (%)

10 (50.0)

107 (43.3)

103 (38.4)

67 (48.9)

134 (37.9)

IR (%)

16.31

10.28

16.45

12.14

11.45

Discontinuations due to any AEs

n (%)

1 (5.0)

1 (0.4)

0

2 (1.5)

1 (0.3)

IR (%)

0.99

0.06

 

0.23

0.06

Any serious AEs

n (%)

0

4 (1.6)

5 (1.9)

8 (5.8)

10 (2.8)

IR (%)

0

0.26

0.55

0.94

0.58

Deaths

n (%)

0

0

0

0

0

AEs by primary SOCs (occurring in ≥5% of patients in any group)

Infections and infestations

n (%)

4 (20.0)

54 (21.9)

40 (14.9)

30 (21.9)

49 (13.8)

IR (%)

4.41

4.05

5.13

4.02

3.17

Musculoskeletal and connective tissue disorders

n (%)

1 (5.0)

22 (8.9)

14 (5.2)

11 (8.0)

27 (7.6)

IR (%)

1.03

1.48

1.62

1.33

1.65

Gastrointestinal disorders

n (%)

1 (5.0)

12 (4.9)

17 (6.3)

12 (8.8)

21 (5.9)

IR (%)

1.04

0.80

1.98

1.44

1.26

Cardiac disorders

n (%)

1 (5.0)

8 (3.2)

4 (1.5)

3 (2.2)

12 (3.4)

IR (%)

1.04

0.53

0.44

0.35

0.71

Eye disorders

n (%)

3 (15.0)

5 (2.0)

6 (2.2)

2 (1.5)

7 (2.0)

IR (%)

3.40

0.33

0.67

0.23

0.41

Renal and urinary disorders

n (%)

1 (5.0)

5 (2.0)

5 (1.9)

5 (3.6)

3 (0.8)

IR (%)

1.04

0.32

0.55

0.58

0.17

Investigations

n (%)

0

12 (4.9)

13 (4.9)

16 (11.7)

15 (4.2)

IR (%)

 

0.79

1.50

1.96

0.89

Skin and subcutaneous tissue disorders

n (%)

0

10 (4.0)

11 (4.1)

7 (5.1)

16 (4.5)

IR (%)

 

0.65

1.25

0.83

0.95

  1. n (%) are expressed as number (%) of patients; incidence rate (IR) is expressed as % per month.
  2. 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.
  3. SOC system organ class.