Table 2.
rIX-FP, N (%) E | |||
---|---|---|---|
Prophylaxis | On demand | Total | |
Number of subjects | 13 | 4 | 17 |
AE leading to study withdrawal | 0 | 0 | 0 |
Serious AEs (SAEs) | 0 | 0 | 0 |
Any AEs | 13 (100.0) 45 | 1 (25.0) 1 | 14 (82.4) 46 |
Severity of AEs | |||
Mild | 13 (100.0) 42 | 1 (25.0) 1 | 14 (82.4) 43 |
Moderate | 2 (15.4) 3 | 0 | 2 (11.8) 3 |
Severe | 0 | 0 | 0 |
AEs related to rIX-FP | 0 | 0 | 0 |
rIX-FP, coagulation factor IX (recombinant), albumin fusion protein; N, number of subjects with AEs; AE, adverse events.