TABLE 4.
QBB4‐1, number of subjects with treatment‐related adverse events (TRAEs) and number of TRAEs by rescue medication.
| Without rescue medication | With rescue medication | Total | |
|---|---|---|---|
| n (%) | 62 (46.3) | 72 (53.7) | 134 (100.0) |
| TRAEs number (n [%]) | 5 (8.1) | 8 (11.1) | 13 (9.7) |
| General disorders and administration site conditions | 1 (1.6) | 3 (4.2) | 4 (3.0) |
| Application site acne | 1 (1.6) | 1 (1.4) | 2 (1.5) |
| Application site irritation | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Application site urticaria | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Infections and infestations | 4 (6.5) | 5 (6.9) | 9 (6.7) |
| Application site folliculitis | 1 (1.6) | 3 (4.2) | 4 (3.0) |
| Folliculitis | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Herpes simplex | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Impetigo | 1 (1.6) | 0 (0.0) | 1 (0.7) |
| Molluscum contagiosum | 2 (3.2) | 0 (0.0) | 2 (1.5) |
| Oral herpes | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Skin infection | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 0 (0.0) | 1 (1.4) | 1 (0.7) |
| Skin papilloma | 0 (0.0) | 1 (1.4) | 1 (0.7) |
Note: TRAEs were coded according to MedDRA/J V.21.0.