Table 5

Summary of adverse events through 24 weeks

AMG 108


Placebo

(n = 201)

50 mg

(n = 202)

125 mg

(n = 201)

250 mg

(n = 201)

Totala

(n = 604)


Any AE

133 (66.2)

134 (66.3)

143 (71.1)

135 (67.2)

412 (68.2)

Most common AE

Headache

16 (8.0)

11 (5.4)

15 (7.5)

15 (7.5)

41 (6.8)

Diarrhea

13 (6.5)

10 (5.0)

11 (5.5)

15 (7.5)

36 (6.0)

Nasopharyngitis

18 (9.0)

11 (5.4)

13 (6.5)

12 (6.0)

36 (6.0)

URI

15 (7.5)

10 (5.0)

13 (6.5)

13 (6.5)

36 (6.0)

Treatment-related AE

48 (23.9)

43 (21.3)

50 (24.9)

45 (22.4)

138 (22.8)

AE leading to:

Study discontinuation

1 (0.5)

3 (1.5)

3 (1.5)

3 (1.5)

9 (1.5)

Withdrawal of study drug

2 (1.0)

4 (2.0)

4 (2.0)

3 (1.5)

11 (1.8)

Hospitalization

9 (4.5)

5 (2.5)

5 (2.5)

6 (3.0)

16 (2.6)

Any infection

72 (35.8)

64 (31.7)

68 (33.8)

62 (30.8)

194 (32.1)

Infection leading to:

Study discontinuation

1 (0.5)

0

0

1 (0.5)

1 (0.2)

Withdrawal of study drug

0

1 (0.5)

0

1 (0.5)

2 (0.3)

Hospitalization

3 (1.5)

1 (0.5)

1 (0.5)

2 (1.0)

4 (0.7)

Injection site reaction

5 (2.5)

8 (4.0)

10 (5.0)

9 (4.5)

27 (4.5)

Any serious AE

11 (5.5)

6 (3.0)

6 (3.0)

9 (4.5)

21 (3.5)

Treatment-related serious AE

2 (1.0)

2 (1.0)

1 (0.5)

1 (0.5)

4 (0.7)

Serious infection

3 (1.5)

2 (1.0)

1 (0.5)

2 (1.0)

5 (0.8)

Death

0

0

0

0

0


Data presented as n (%). AE, adverse event; URI, upper respiratory infection. aAll randomized patients who received at least one dose of AMG 108.

Cardiel et al. Arthritis Research & Therapy 2010 12:R192   doi:10.1186/ar3163

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