Table 5 |
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|
Summary of adverse events through 24 weeks |
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|
AMG 108 |
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|
|
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|
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 |
|
|
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|
Data presented as n (%). AE, adverse event; URI, upper respiratory infection. aAll randomized patients who received at least one dose of AMG 108. |
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|
Cardiel et al. Arthritis Research & Therapy 2010 12:R192 doi:10.1186/ar3163 |
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