Table 3.
Treatment area all-cause and treatment-related AEs by preferred term reported for ≥ 1 patients
| Treatment area AEs,a n (%) N = 137 |
||
|---|---|---|
| All-cause | Treatment-related | |
| Dermatitis atopica | 8 (5.8) | 0 |
| Application site pain | 5 (3.6) | 5 (3.6) |
| Eczemaa | 5 (3.6) | 2 (1.5) |
| Application site discomfort | 4 (2.9) | 4 (2.9) |
| Erythema | 4 (2.9) | 4 (2.9) |
| Application site erythema | 4 (2.9) | 3 (2.2) |
| Dermatitis contact | 4 (2.9) | 1 (0.7) |
| Dermatitis diaper | 4 (2.9) | 0 |
| Rash | 4 (2.9) | 0 |
| Pruritus | 3 (2.2) | 3 (2.2) |
| Application site reaction | 2 (1.5) | 2 (1.5) |
| Rash pustular | 2 (1.5) | 0 |
| Application site irritation | 1 (0.7) | 1 (0.7) |
| Application site pruritus | 1 (0.7) | 1 (0.7) |
| Skin irritation | 1 (0.7) | 1 (0.7) |
| Roseola | 1 (0.7) | 0 |
| Molluscum contagiosum | 1 (0.7) | 0 |
| Dermatitis infected | 1 (0.7) | 0 |
| Impetigo | 1 (0.7) | 0 |
| Dermatitis allergic | 1 (0.7) | 0 |
| Rash papular | 1 (0.7) | 0 |
| Therapeutic procedure | 1 (0.7) | 0 |
AD atopic dermatitis, AE adverse event
a‘Dermatitis atopic’ or ‘eczema’ may have been AD worsening/flare or a new AD lesion. A total of 13 patients experienced treatment area TEAEs that reflected symptoms of AD (‘dermatitis atopic’ or ‘eczema’) during the study. Of these 13 patients, eight had TEAE onset that occurred on or before day 29, and the other five had TEAE onset that occurred after day 29 (after crisaborole treatment)