Number of patients (%) | ||
---|---|---|
Year 1 (n = 290) | Year 2 (n = 220) | |
Patients with AEs | 218 (75.2) | 131 (59.6) |
Number of AEs | 630 | 263 |
Most frequent AEsa | ||
Any application site disorderb | 100 (34.5) | 36 (16.4) |
Nasopharyngitis | 25 (8.6) | 9 (4.1) |
Back pain | 20 (6.9) | 10 (4.5) |
Erythema | 19 (6.6) | 2 (0.9) |
Nausea | 14 (4.8) | 2 (0.9) |
Pruritus | 11 (3.8) | 2 (0.9) |
Insomnia | 11 (3.8) | 1 (0.5) |
Hypertension | 10 (3.4) | 4 (1.8) |
Fatigue | 9 (3.1) | 5 (2.3) |
Bronchitis | 9 (3.1) | 5 (2.3) |
Sleep disorder | 9 (3.1) | 5 (2.3) |
Patients with serious AEs | 21 (7.2) | 21 (9.5) |
Number of serious AEs | 24 | 22 |