Table 3.
Summary of overall treatment-emergent adverse events (TEAEs) and TEAEs observed in at least 5% of patients in any treatment group
| Adult patients (n = 166) | Pediatric patients (n = 200) | |
|---|---|---|
| Overall TEAEs | ||
| Patients with any TEAEs | 120 (72.3) | 178 (89.0) |
| Patients with mild TEAEs | 90 (54.2) | 134 (67.0) |
| Patients with moderate TEAEs | 27 (16.3) | 44 (22.0) |
| Patients with severe TEAEs | 3 (1.8) | 0 (0.0) |
| Patients with serious TEAEs | 2 (1.2) | 1 (0.5) |
| Deaths | 0 (0.0) | 0 (0.0) |
| TEAEs observed in at least 5% of patients in any treatment group | ||
| Eye disorders | ||
| Conjunctivitis allergic | 5 (3.0) | 21 (10.5) |
| Infections and infestations | ||
| Influenza | 5 (3.0) | 25 (12.5) |
| Gastroenteritis | 5 (3.0) | 17 (8.5) |
| Pharyngitis | 0 (0.0) | 10 (5.0) |
| Bronchitis | 1 (0.6) | 12 (6.0) |
| Nasopharyngitis | 24 (14.5) | 64 (32.0) |
| Molluscum contagiosum | 0 (0.0) | 10 (5.0) |
| Impetigo | 2 (1.2) | 31 (15.5) |
| Folliculitis | 10 (6.0) | 14 (7.0) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | ||
| Skin papilloma | 4 (2.4) | 10 (5.0) |
| Skin and subcutaneous tissue disorders | ||
| Acne | 8 (4.8) | 9 (4.5) |
| Dermatitis atopic | 35 (21.1) | 47 (23.5) |
| Dermatitis contact | 5 (3.0) | 12 (6.0) |
| Urticaria | 8 (4.8) | 17 (8.5) |
Data are number of patients (%) unless otherwise indicated. TEAEs were coded to preferred terms according to the Medical Dictionary for Regulatory Activities (MedDRA) version 22.1
TEAEs treatment-emergent adverse events