Table 5 Adverse event (AE) profile of C1-INH (SC) in female subjects
Adverse events | All female subjects (n = 76) | Females of childbearing age (n = 42) | Overall study population (N = 126) |
|---|---|---|---|
No. of events | |||
Any AE | 911 | 568 | 1811 |
AEs leading to discontinuation | 4 | 2 | 4 |
Related AEs | 505 | 348 | 1257 |
Serious AEs | 9 | 3 | 12 |
Related serious AEs | 0 | 0 | 0 |
Severity | |||
Mild | 734 | 473 | 1572 |
Moderate | 161 | 87 | 218 |
Severe | 16 | 8 | 21 |
Outcome | |||
Recovered/resolved | 869 | 548 | 1758 |
Solicited AEs (injection-site reactions | 1251 | ||
Severity | |||
Mild | 488 | 339 | 1234 |
Moderate | 9 | 5 | 17 |
Severe | 0 | 0 | 0 |
Outcome | |||
Recovered/resolved | 497 | 344 | 1251 |