Table 4.
Summary of treatment-emergent AEs including IRs and gout flares reported11
| Safety characteristics (No.) | GOUT 1 and 2 |
GOUT 3 |
|||
|---|---|---|---|---|---|
| Placebo (N = 43) | Pegloticase q2 wk (N = 85) | Pegloticase q4 wk (N = 84) | Pegloticase q2 wk (N = 85) | Pegloticase q4 wk (N = 84) | |
| Adverse events (AEs) | 370 | 693 | 870 | 1,044 | 1,411 |
| Subjects with AEs | 41 (95%) | 80 (94%) | 84 (100%) | 83 (98%) | 84 (100%) |
| Subjects with serious AEs (SAE) | 5 (12%) | 20 (24%) | 19 (23%) | 24 (28%) | 27 (32%) |
| Subjects with infections | 22 (51%) | 30 (35%) | 40 (48%) | 41 (48%) | 54 (64%) |
| Subjects with serious infections | 4 (9%) | 3 (4%) | 5 (6%) | 3 (4%) | 7 (8%) |
| Subjects with malignancy | 1 (2%) | 0 (0%) | 1 (1%) | 0 (0%) | 1 (1%) |
| Subjects with infusion reactions (IR) | 2 (5%) | 22 (26%) | 34 (41%) | 26 (31%) | 38 (45%) |
| Subjects who discontinued due to AEs | 1 (2%) | 16 (19%) | 17 (20%) | 18 (21%) | 21 (25%) |
| Deaths | 1 (2%) | 3 (4%) | 1 (1%) | 0 (0%) | 2 (2%) |
Note: Except for the “number of AEs”, subjects are counted only once in each row.