Table 4.
Incidence of treatment‐emergent adverse events (TEAE) in safety analysis set
| Sofpironium (n = 141) | Vehicle (n = 140) | |
|---|---|---|
| Incidence, n (%) | ||
| TEAE | ||
| Any | 62 (44.0) | 43 (30.7) |
| Drug‐related | 23 (16.3) | 7 (5.0) |
| Serious | 0 | 2 (1.4) |
| Discontinuation due to TEAE | 1 (0.7) | 0 |
| Death | 0 | 0 |
| TEAE by severity | ||
| Mild | 60 (42.6) | 38 (27.1) |
| Moderate | 2 (1.4) | 4 (2.9) |
| Severe | 0 | 1 (0.7) |
| Common TEAE reported in >2% of patients in sofpironium group | ||
| Nasopharyngitis | 20 (14.2) | 8 (5.7) |
| Dermatitis at the application site | 12 (8.5) | 3 (2.1) |
| Erythema at the application site | 8 (5.7) | 1 (0.7) |
| Eczema | 6 (4.3) | 5 (3.6) |
| Miliaria | 5 (3.5) | 1 (0.7) |
| Acne | 2 (1.4) | 4 (2.9) |
| Tinea pedis | 3 (2.1) | 0 |
| Pruritus at the application site | 3 (2.1) | 0 |
| Eczema at the application site | 3 (2.1) | 1 (0.7) |
| Anticholinergic TEAE | ||
| Thirst | 2 (1.4) | 0 |
| Constipation | 1 (0.7) | 0 |
| Mydriasis | 1 (0.7) | 0 |
| Headache | 0 | 1 (0.7) |
| Vision blurred | 0 | 1 (0.7) |
MedDRA version 21.1.