Table 4 Adverse events during first year of observation (+/- 3 months). Adverse events reported fewer than three times are not listed, except that there were at least three reported adverse events in one group of patients. (Number of reported cases (in N of patients), % of all reported adverse events). The last two columns describe adverse events recorded in all patients included in BIOREG RA-group with completed 1-year observation (n = 511)

All

64 (56)

100 %

20 (19)

100 %

153 (137)

100 %

SAE

31 (23)

48.4 %

4 (4)

20.0 %

72 (58)

47.1 %

Infections

25 (23)

39.1 %

8 (8)

40.0 %

60 (56)

39.2 %

Ulcerative skin lesions

4 (4)

6.3 %

1 (1)

5.0 %

6 (6)

3.9 %

Malignant diseases

3 (3) ^a

4.7 %

1 (1) ^b

5.0 %

6 (6) ^c

3.9 %

Ophthalmic diseases

3 (3)

4.7 %

0

7 (7)

4.6 %

Thrombotic diseases

3 (3)

4.7 %

1 (1)

5.0 %

4 (4)

2.6 %

Intolerance of biologic drug

1 (1)

1.6 %

3 (3)

15.0 %

9 (9)

5.9 %

Vertigo

3 (2)

4.7 %

0

3 (2)

2.0 %

Others

22(17)

34.4 %

6 (6)

30.0 %

58 (55)

37.9 %