Table 3.
Summary of Safety During Double-Blind Treatment Period (Safety Population)
| d-ATS (all doses) (N = 105a), n (%) | Placebo (N = 105b), n (%) | |
|---|---|---|
| TEAEs | 44 (41.9) | 43 (41.0) |
| Severe TEAEs | 2 (1.9) | 1 (1.0) |
| Serious TEAEs | 0 (0.0) | 0 (0.0) |
| TEAEs leading to discontinuation | 0 (0.0) | 0 (0.0) |
| Preferred term | ||
| Decreased appetite | 13 (12.3) | 2 (1.9) |
| Insomnia | 6 (5.7) | 5 (4.8) |
| Headache | 6 (5.7) | 4 (3.8) |
| Hyperkalemia | 5 (4.8) | 4 (3.8) |
| Vomiting | 4 (3.8) | 0 (0.0) |
| Nasopharyngitis | 3 (2.9) | 2 (1.9) |
| Abdominal pain upper | 3 (2.9) | 1 (1.0) |
| Nausea | 3 (2.9) | 1 (1.0) |
| Affect lability | 3 (2.9) | 0 (0.0) |
| Tic | 2 (1.9) | 0 (0.0) |
| Irritability | 2 (1.9) | 1 (1.0) |
a
One patient discontinued the study before crossing over to d-ATS.
b
One patient was dispensed placebo patches for Visit 6 of the double-blind phase but did not return for any safety assessments.
TEAE, treatment-emergent adverse event.