Table 7.
Overall Incidence of Adverse Events in Safety Population
| Adverse event | Up to 4 hours after treatment | Any time | ||
|---|---|---|---|---|
| Placebo (n=41) | C1-INH 10 U/kg (n=39) | C1-INH 20 U/kg (n=46) | C1-INH all doses (n=108) | |
| Total adverse events, n (%) | 18 (43.9) | 10 (25.6) | 9 (19.6) | 55 (50.9) |
| Possibly related adverse events, n (%) | 8 (19.5) | 8 (20.5) | 5 (10.9) | 29 (26.9) |
| SAE, n (%) | 0 (0.0) | 0 (0.0) | 0 (0,0) | 4 (3.7) |
| Adverse events leading to study D/C, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
D/C=discontinuation; SAE=serious adverse event
Source: Adapted from Craig 2009b.