Table 4.
Summary of safety outcomes, safety population.
| Diclofenac diethylamine 2.32% w/w gel (n = 29), n (%) | Placebo gel (n = 17), n (%) | |
|---|---|---|
| Any AE | 18 (62.1) | 11 (64.7) |
| Any TEAE | 16 (55.2) | 10 (58.8) |
| Serious TEAEs | 1 (3.4) | 0 |
| Treatment-related TEAEs | 0 | 0 |
| TEAEs leading to treatment discontinuation | 0 | 0 |
| TEAEs leading to study discontinuation | 0 | 0 |
| Deaths | 0 | 0 |
| TEAEs occurring in ⩾2 participants in either arm | ||
| Nausea | 5 (17.2) | 2 (11.8) |
| Vomiting | 4 (13.8) | 1 (5.9) |
| Fall | 3 (10.3) | 0 |
| Bursal fluid accumulation | 2 (6.9) | 1 (5.9) |
| C-reactive protein increased | 2 (6.9) | 1 (5.9) |
| Dizziness | 0 | 2 (11.8) |
AE, adverse event; TEAE, treatment-emergent adverse event.