Blood Research

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
Aspergillus infection 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.

Blood Res 2020;55:246~252 https://doi.org/10.5045/br.2020.2020225
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