Table 3.
Summary of adverse events
| TA-ER 32 mg N = 324 |
Saline-placebo N = 262 |
TAcs 40 mg N = 212 |
|
|---|---|---|---|
| ≥ 1 TEAE, n (%) | 168 (51.9) | 129 (49.2) | 119 (56.1) |
| Grade 1 | 78 (24.1) | 51 (19.5) | 54 (25.5) |
| Grade 2 | 77 (23.8) | 65 (24.8) | 59 (27.8) |
| Grade 3 | 11 (3.4) | 13 (5.0) | 4 (1.9) |
| Grade 4 | 2 (0.6) | 0 | 2 (0.9) |
| ≥ 1 serious TEAE | 10 (3.1) | 3 (1.1) | 4 (1.9) |
| ≥ 1 TEAE leading to study discontinuation | 4 (1.2) | 2 (0.8) | 1 (0.5) |
| TEAE by maximum relationship | |||
| Not related | 133 (41.0) | 108 (41.2) | 93 (43.9) |
| Unlikely | 18 (5.6) | 13 (5.0) | 13 (6.1) |
| Possibly, probably, or definitely related | 17 (5.2) | 8 (3.1) | 13 (6.1) |
| ≥ 1 index-knee TEAE | 53 (16.4) | 37 (14.1) | 22 (10.4) |
| ≥ 1 index-knee TEAE leading to study discontinuation | 3 (0.9) | 2 (0.8) | 1 (0.5) |
TAcs triamcinolone acetonide crystalline suspension, TA-ER triamcinolone acetonide extended-release, TEAE treatment-emergent adverse event