AEs in PwHA who received ≥1 prophylactic rurioctocog alfa pegol dose (randomized PwHA in SAS*)
| . | FVIII trough level 1% to 3% (n = 57) . | FVIII trough level 8% to 12% (n = 58) . | All PwHA (N = 115) . |
|---|---|---|---|
| Nonserious and serious AEs* | |||
| All AEs, n | 101 | 103 | 204 |
| PwHA with AEs, n (%) | 34 (59.6) | 36 (62.1) | 70 (60.9) |
| AEs considered related to rurioctocog alfa pegol,† n | 2 | 2 | 4 |
| Nonserious AEs | |||
| All nonserious AEs, n | 97 | 98 | 195 |
| PwHA with nonserious AEs, n (%) | 32 (56.1) | 35 (60.3) | 67 (58.3) |
| Serious AEs | |||
| All serious AEs, n | 4 | 5 | 9‡ |
| PwHA with serious AEs, n (%) | 3 (5.3) | 4 (6.9) | 7 (6.1) |
| Serious AEs considered related to rurioctocog alfa pegol,† n | 0 | 1 | 1 |
| Anti-FVIII inhibitory antibodies, n | 0 | 1§ | 1§ |
| Death, n | 0 | 0 | 0 |
| . | FVIII trough level 1% to 3% (n = 57) . | FVIII trough level 8% to 12% (n = 58) . | All PwHA (N = 115) . |
|---|---|---|---|
| Nonserious and serious AEs* | |||
| All AEs, n | 101 | 103 | 204 |
| PwHA with AEs, n (%) | 34 (59.6) | 36 (62.1) | 70 (60.9) |
| AEs considered related to rurioctocog alfa pegol,† n | 2 | 2 | 4 |
| Nonserious AEs | |||
| All nonserious AEs, n | 97 | 98 | 195 |
| PwHA with nonserious AEs, n (%) | 32 (56.1) | 35 (60.3) | 67 (58.3) |
| Serious AEs | |||
| All serious AEs, n | 4 | 5 | 9‡ |
| PwHA with serious AEs, n (%) | 3 (5.3) | 4 (6.9) | 7 (6.1) |
| Serious AEs considered related to rurioctocog alfa pegol,† n | 0 | 1 | 1 |
| Anti-FVIII inhibitory antibodies, n | 0 | 1§ | 1§ |
| Death, n | 0 | 0 | 0 |
AEs that occurred after the first randomized dose was received until study end; excludes any AEs that occurred during the surgical period.
Per investigator and sponsor assessment.
Four serious AEs in 3 PwHA with 1% to 3% FVIII trough levels (moderate severity: 1 limb abscess, 1 event of cellulitis, 1 event of appendicitis, 1 radius fracture) and 5 serious AEs in 4 PwHA with 8% to 12% FVIII trough levels (moderate severity: 1 hand fracture, 1 head injury, 1 event of multiple injuries; mildly serious AEs: 1 laceration, 1 event of FVIII inhibition).
Transient low-titer anti-FVIII inhibitory antibodies (0.6 BU at week 8) that resolved before study end. Anti-FVIII binding antibodies for this patient were negative throughout the study.