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Number of patients experiencing any adverse event or serious adverse event (FAS analysis; N = 45)
|
HFC (N = 22) |
Cryoprecipitate (N = 23) |
|
|---|---|---|
| AE, n | 225 | 228 |
| Patients with AE, n (%) | 22 (100) | 23 (100) |
| Severity of AE, n | ||
| Mild | 222 | 214 |
| Moderate | 2 | 12 |
| Severe | 1 | 2 |
| Probably or possibly related AE, n | 0 | 0 |
| SAE, n | 6 | 17 |
Abbreviations: AE, adverse event; FAS, full analysis set; HFC, human fibrinogen concentrate; SAE, serious adverse event.
