Table 2.
Treatment-emergent adverse events (TEAEs) by preferred term in the safety analysis set
| Subdivision of study timeline (epoch) | Treatment sequence 1 (N = 20) | Treatment sequence 2 (N = 20) | ||
|---|---|---|---|---|
| Epoch 1 (TCA) | Epoch 2 (TCA + LOR) | Epoch 1 (LOR) | Epoch 2 (LOR + TCA) | |
| Injection site bruising | 4/4 (20%) | 0/0 | 1/1 (5%) | 2/2 (10%) |
| Injection site pain | 0/0 | 2/1 (5%) | 0/0 | 0/0 |
| Back pain | 1/1 (5%) | 0/0 | 0/0 | 0/0 |
| Flank pain | 0/0 | 1/1 (5%) | 0/0 | 0/0 |
| Musculoskeletal discomfort | 0/0 | 1/1 (5%) | 0/0 | 0/0 |
| Extremity pain | 0/0 | 1/1 (5%) | 0/0 | 0/0 |
| Headache | 0/0 | 1/1 (5%) | 1/1 (5%) | 0/0 |
| Hypersensitivity | 0/0 | 0/0 | 0/0 | 1/1 (5%) |
| Skin abrasion | 0/0 | 1/1 (5%) | 0/0 | 0/0 |
| Adnexa uteri pain | 0/0 | 1/1 (5%) | 0/0 | 0/0 |
| Total TEAEs [events/n (%)] | 5/4 (20%) | 8/3 (15%) | 2/2 (10%) | 3/3 (15%) |
TCA triamcinolone acetonide, LOR lorecivivint, TEAEs treatment-emergent adverse events