Summary of AEs during the OLE study
| All treated patients (N=149) | |
|---|---|
| AEs in the OLE study | N (%) |
| Subjects with any AE | 146 (98) |
| Subjects with any serious AE | 51 (34) |
| Subjects with serious AEs considered related to pegloticase | 13 (9) |
| Discontinuations due to AE | 11 (7) |
| Most common AEs (incidence >10%) | |
| Gout flare | 106 (71) |
| Infusion-related reaction | 65 (44) |
| Arthralgia | 29 (20) |
| Upper respiratory tract infection | 27 (18) |
| Pain in extremity | 26 (17) |
| Back pain | 25 (17) |
| Diarrhoea | 22 (15) |
| Peripheral oedema | 21 (14) |
| Urinary tract infection | 20 (13) |
| Nausea | 17 (11) |
| Headache | 16 (11) |
| Fatigue | 15 (10) |
| Sinusitis | 15 (10) |
| Nasopharyngitis | 15 (10) |
AE, adverse event; OLE, open-label extension.