Table 2.
Overall all-cause TEAEs by preferred term reported for ≥ 2.5% of patients and corresponding treatment-related rates
| Overall TEAEs,a n (%) N = 137 |
||
|---|---|---|
| All-cause | Treatment-related | |
| Pyrexia | 13 (9.5) | 0 |
| Upper respiratory tract infection | 10 (7.3) | 1 (0.7) |
| Diarrhea | 10 (7.3) | 0 |
| Dermatitis atopica | 9 (6.6) | 0 |
| Dermatitis diaper | 9 (6.6) | 0 |
| Cough | 7 (5.1) | 0 |
| Otitis media | 6 (4.4) | 1 (0.7) |
| Eczemaa | 5 (3.6) | 2 (1.5) |
| Application site pain | 5 (3.6) | 5 (3.6) |
| Conjunctivitis | 5 (3.6) | 0 |
| Rhinorrhea | 5 (3.6) | 0 |
| Dermatitis contact | 4 (2.9) | 1 (0.7) |
| Erythema | 4 (2.9) | 4 (2.9) |
| Rash | 4 (2.9) | 0 |
| Application site discomfort | 4 (2.9) | 4 (2.9) |
| Application site erythema | 4 (2.9) | 3 (2.2) |
| Ear infection | 4 (2.9) | 0 |
| Nasopharyngitis | 4 (2.9) | 0 |
| Teething | 4 (2.9) | 0 |
AD atopic dermatitis, TEAE treatment-emergent adverse event
a‘Dermatitis atopic’ or ‘eczema’ may have been AD worsening/flare or a new AD lesion. A total of 14 patients experienced TEAEs that reflected symptoms of AD (‘dermatitis atopic’ or ‘eczema’) during the study. Of these 14 patients, eight had TEAE onset that occurred on or before day 29, and the other six had TEAE onset that occurred after day 29 (after crisaborole treatment)