Table 5 Summary of adverse events through 24 weeks
| Â | Â | AMG 108 | |||
|---|---|---|---|---|---|
| Â | 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 | Â | Â | Â | Â | Â |
   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: | Â | Â | Â | Â | Â |
   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: | Â | Â | Â | Â | Â |
   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 |