Table 4.
Patch Application-Site Treatment-Emergent Adverse Events (Safety Population)
| Dose-optimization period, n (%) |
Double-blind period, n (%) |
||
|---|---|---|---|
| d-ATS (all doses) (N = 110) | d-ATS (all doses) (N = 105a) | Placebo (N = 105b) | |
| Pain | 11 (10.0) | 0 (0.0) | 0 (0.0) |
| Pruritus | 8 (7.3) | 0 (0.0) | 0 (0.0) |
| Burn | 3 (2.7) | 0 (0.0) | 0 (0.0) |
| Erythema | 2 (1.8) | 1 (1.0) | 0 (0.0) |
| Discomfort | 1 (0.9) | 0 (0.0) | 0 (0.0) |
| Edema | 1 (0.9) | 0 (0.0) | 0 (0.0) |
| Swelling | 1 (0.9) | 1 (1.0) | 0 (0.0) |
One patient discontinued the study before crossing over to d-ATS.
One patient was dispensed placebo patches for Visit 6 of the double-blind phase but did not return for any safety assessments.