Table 7.
Adverse Events Overview in the Retreatment Phase
| G2 (n = 125) |
PG (n = 74) |
|||
|---|---|---|---|---|
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| Total AEs | 68 (54.4%) | 151 | 43 (58.1%) | 106 |
| Serious AEs | 3 (2.4%) | 3 | 1 (1.4%) | 3 |
| Unanticipated related serious AEs | 0 (0.0%) | 0 | 0 (0.0%) | 0 |
| Total related AEs | 26 (20.8%) | 48 | 13 (17.6%) | 20 |
| Related AEs occurring within 24 hours of IA injection | 13 (10.4%) | 16 | 3 (4.1%) | 4 |
| Related AEs occurring in ≥5% | ||||
| Joint swelling | 12 (9.6%) | 12 | 5 (6.8%) | 5 |
| Joint effusion | 9 (7.2%) | 9 | 5 (6.8%) | 5 |
| Arthralgia | 12 (9.6%) | 13 | 6 (8.1%) | 6 |
Note: AE = adverse event; PBS = phosphate-buffered saline. G2 group received a second Gel-200 injection. PG group received a Gel-200 injection following an initial PBS injection. No statistically significant differences were identified between treatment groups.