Summary of adverse events (safety analysis set, N=57).
AEs (PTa)) | N of patients (%) | N of AEs | Unexpected AEs | Serious AEs |
---|---|---|---|---|
Hemophilic arthropathy | 2 (3.5) | 2 | 2 | 2 |
Cataract | 1 (1.8) | 1 | 1 | 0 |
Upper abdominal pain | 1 (1.8) | 1 | 1 | 0 |
1 (1.8) | 1 | 1 | 0 | |
Tinea pedis | 1 (1.8) | 1 | 1 | 0 |
Procedural pain | 1 (1.8) | 1 | 1 | 0 |
Anti-factor IX antibody increasedb) | 1 (1.8) | 1 | 1 | 1 |
Hyperuricemia | 1 (1.8) | 1 | 1 | 0 |
Insomnia | 1 (1.8) | 1 | 1 | 0 |
Hematuria | 1 (1.8) | 1 | 1 | 0 |
Total | 8 (14.0) | 11 | 11 | 3 |
a)Dictionary: MedDRA (version: 21.1). b)Confirmatory test was negative for this.
Abbreviations: AE, adverse events; PT, preferred term.