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Table 4 Incidence of serious adverse events by primary SOC

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

Infections and infestations

n (%)

0

1 (0.4)

1 (0.4)

3 (2.2)

2 (0.6)

IR (%)

 

0.06

0.11

0.34

0.12

Renal and urinary disorders

n (%)

0

1 (0.4)

2 (0.7)

1 (0.7)

1 (0.3)

IR (%)

 

0.06

0.22

0.11

0.06

Gastrointestinal disorders

n (%)

0

0

1 (0.4)

1 (0.7)

1 (0.3)

IR (%)

  

0.11

0.11

0.06

Cardiac disorders

n (%)

0

0

0

1 (0.7)

5 (1.4)

IR (%)

   

0.11

0.29

Hepatobiliary disorders

n (%)

0

0

1 (0.4)

0

1 (0.3)

IR (%)

  

0.11

 

0.06

General disorders and administration site conditions

n (%)

0

0

0

0

1 (0.3)

IR (%)

    

0.06

Musculoskeletal and connective tissue disorders

n (%)

0

1 (0.4)

0

0

1 (0.3)

IR (%)

 

0.06

  

0.06

Metabolism and nutrition disorders

n (%)

0

0

0

2 (1.5)

0

IR (%)

   

0.23

 

Investigations

n (%)

0

0

0

1 (0.7)

0

IR (%)

   

0.11

 

Neoplasms—benign, malignant and unspecified (including cysts and polyps)

n (%)

0

0

0

1 (0.7)

0

IR (%)

   

0.11

 

Injury, poisoning and procedural complications

n (%)

0

0

1 (0.4)

0

0

IR (%)

  

0.11

  

Nervous system disorders

n (%)

0

1 (0.4)

0

0

0

IR (%)

 

0.06

   

Reproductive system and breast disorders

n (%)

0

1 (0.4)

0

0

0

IR (%)

 

0.06

   
  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.