Overall summary of rFIXFc TEAEs
| . | Overall (N = 33) . |
|---|---|
| Total no. of TEAEs* | 387 |
| Patients with ≥1 TEAE, n (%) | 30 (90.9) |
| Patients with ≥1 related TEAE%, n (%)† | 2 (6.1) |
| Patients who discontinued treatment and/or study because of AE, n (%) | 1 (3.0) |
| Total no. of TESAEs‡ | 58 |
| Patients with ≥1 TESAE, n (%) | 23 (69.7) |
| Patients with ≥1 related TESAE, n (%)† | 1 (3.0)§ |
| Deaths, n (%) | 0 (0.0) |
| . | Overall (N = 33) . |
|---|---|
| Total no. of TEAEs* | 387 |
| Patients with ≥1 TEAE, n (%) | 30 (90.9) |
| Patients with ≥1 related TEAE%, n (%)† | 2 (6.1) |
| Patients who discontinued treatment and/or study because of AE, n (%) | 1 (3.0) |
| Total no. of TESAEs‡ | 58 |
| Patients with ≥1 TESAE, n (%) | 23 (69.7) |
| Patients with ≥1 related TESAE, n (%)† | 1 (3.0)§ |
| Deaths, n (%) | 0 (0.0) |
Percentages are based on overall number of patients.
Includes TESAEs.
AEs with undefined relationship were included with related AEs.
TESAEs reported in 1 patient each were: anemia, FIX inhibition, immune thrombocytopenic purpura, phimosis, inguinal hernia, tongue hemorrhage, vessel puncture-site hematoma, hypersensitivity, croup infectious, gastroenteritis, infusion-site pustule, lower respiratory tract infection, respiratory tract infection, staphylococcal bacteremia, viral infection, viral rash, accidental exposure to product, closed head injury (craniocerebral injury), face injury, skull fracture, subdural hematoma, compartment syndrome, hemarthrosis, coma, febrile convulsion, spinal cord hematoma, tongue biting, redundant prepuce, and hematoma.
This patient had hypersensitivity reaction and tested positive for inhibitor development and discontinued study because of AEs.