Table 1.
Summary of adverse events
| n (%) | Placebo | BI 655064 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IV | SC | IV + SC (n = 54) |
|||||||||||
| IV (n = 12) |
SC (n = 6) |
0.2 mg (n = 3) |
0.6 mg (n = 3) |
2 mg (n = 6) |
6 mg (n = 6) |
20 mg (n = 6) |
60 mg (n = 6) |
120 mg (n = 6) |
40 mg (n = 6) |
80 mg (n = 6) |
120 mg (n = 6) |
||
| Any AEs | 6 (50) | 3 (50) | 1 (33) | 2 (67) | 2 (33) | 3 (50) | 0 | 3 (50) | 4 (67) | 3 (50) | 1 (17) | 3 (50) | 22 (41) |
| Severe AEs | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 0 | 0 | 0 | 1 (2) |
| Serious AEsa | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 0 | 0 | 0 | 1 (2) |
| Most common AEsb | |||||||||||||
| Headache | 0 | 1 (17) | 1 (33) | 1 (33) | 1 (17) | 1 (17) | 0 | 1 (17) | 0 | 1 (17) | 1 (17) | 2 (33) | 9 (17) |
| Nasopharyngitis | 1 (8) | 1 (17) | 0 | 0 | 1 (17) | 0 | 0 | 0 | 2 (33) | 1 (17) | 0 | 1 (17) | 5 (9) |
| Oropharyngeal pain | 0 | 0 | 0 | 1 (33) | 0 | 0 | 0 | 1 (17) | 0 | 1 (17) | 0 | 0 | 3 (6) |
aBoth subjects experiencing a serious AE required hospitalisation
bAEs occurring in ≥ 2 subject receiving BI 655064 are reported