Table 2 Reported adverse events during canakinumab treatment in FMF, MKD and TRAPS patients

Total number of AEs reported during canakinumab

9

8

1

Patients with at least one AE

7 (22.6)

6 (23.1)

1 (14.3)

Number of AEs reported per patient

0

24 (77.4)

20 (76.9)

6 (85.7)

1

6 (19.3)

4 (15.4)

1 (14.3)

2

0 (0.0)

2 (7.7)

0 (0.0)

3

1 (3.2)

0 (0.0)

0 (0.0)

At least one AE suspected to be related to canakinumab exposure

5 (16.1)

5 (19.2)

1 (14.3)

At least one serious AE* during canakinumab exposure

4 (12.9)

1 (3.8)

1 (14.3)

At least one serious AE* suspected to be related to canakinumab exposure

2 (6.4)

0 (0.0)

1 (14.3)

At least one AE leading to canakinumab discontinuation

2 (6.4)

1 (3.8)

1 (14.3)

Among reported AEs, types of AEs

N = 9

N = 8

N = 1

Infections

5 (55.5)

3 (37.5)

1 (100.0)

Skin and subcutaneous tissue disorders

2 (22.2)

2 (25.0)

0 (0.0)

Gastro-intestinal disorders

1 (11.1)

0 (0.0)

0 (0.0)

Nutrition disorders

1 (11.1)

0 (0.0)

0 (0.0)

Renal disorders

0 (0.0)

1 (12.5)

0 (0.0)

Lipid metabolism disorders

0 (0.0)

1 (12.5)

0 (0.0)

Nervous system disorders

0 (0.0)

1 (12.5)

0 (0.0)