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Overall summary of AEs.
| Gel-200 (N = 653) |
PBS (N = 538) |
|||
|---|---|---|---|---|
| Patients, No. (%) | Events, n | Patients, No. (%) | Events, n | |
| Total AEs | 356 (54.5) | 902 | 278 (51.7) | 637 |
| Serious AEs | 15 (2.3) | 26 | 6 (1.1) | 7 |
| Related AEs | 92 (14.1) | 163 | 60 (11.2) | 100 |
| Related AEs occurring in ≥5% of patients | ||||
| Joint swelling | 103 (15.8) | 125 | 78 (14.5) | 87 |
| Joint effusion | 88 (13.5) | 103 | 62 (11.5) | 74 |
| Arthralgia | 87 (13.3) | 107 | 57 (10.6) | 72 |
Abbreviation: AEs, adverse events.
