Table 6.
Adverse events occurring in 2% or more of patients in the pooled safety population by time period
| Onset of adverse events | ||||
|---|---|---|---|---|
| Week 0–12 (n = 506) | Week 12–24 (n = 463) | Week 24–36 (n = 417) | Week 36–52 (n = 279) | |
| Eye disorders | ||||
| Allergic conjunctivitis | 2 (0.4) | 2 (0.4) | 5 (1.2) | 2 (0.7) |
| Gastrointestinal disorders | ||||
| Dental caries | 4 (0.8) | 2 (0.4) | 4 (1.0) | 1 (0.4) |
| General disorders and administration site conditions | ||||
| Application site acne | 10 (2.0) | 3 (0.6) | 2 (0.5) | 4 (1.4) |
| Immune system disorders | ||||
| Seasonal allergy | 0 | 0 | 6 (1.4) | 4 (1.4) |
| Infections and infestations | ||||
| Application site folliculitis | 6 (1.2) | 6 (1.3) | 2 (0.5) | 5 (1.8) |
| Folliculitis | 4 (0.8) | 6 (1.3) | 0 | 2 (0.7) |
| Gastroenteritis | 3 (0.6) | 2 (0.4) | 5 (1.2) | 3 (1.1) |
| Herpes simplex | 9 (1.8) | 4 (0.9) | 1 (0.2) | 6 (2.2) |
| Influenza | 0 | 4 (0.9) | 11 (2.6) | 2 (0.7) |
| Kaposi’s varicelliform eruption | 10 (2.0) | 2 (0.4) | 5 (1.2) | 3 (1.1) |
| Nasopharyngitis | 48 (9.5) | 51 (11.0) | 47 (11.3) | 27 (9.7) |
| Oral herpes | 5 (1.0) | 3 (0.6) | 3 (0.7) | 4 (1.4) |
| Paronychia | 4 (0.8) | 4 (0.9) | 2 (0.5) | 1 (0.4) |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 10 (2.0) | 6 (1.3) | 4 (1.0) | 5 (1.8) |
| Contact dermatitis | 11 (2.2) | 8 (1.7) | 3 (0.7) | 5 (1.8) |
| Eczema | 4 (0.8) | 5 (1.1) | 1 (0.2) | 0 |
Data are displayed as number of patients (%).