Table 1.
Treatment-related adverse events experienced by ≥2% of patients (N=277)
| SYSTEM ORGAN CLASS/PREFERRED TERM | MILD n (%) | MODERATE n (%) | SEVERE n (%) | TOTAL n (%) |
|---|---|---|---|---|
| Patients with at least one event | 142 (51.3) | 126 (45.5) | 54 (19.5) | 245 (88.4) |
| Skin and appendages | 87 (31.4) | 101 (36.5) | 53 (19.1) | 241 (87.0) |
| Application-site reactions | 4 (1.4) | 9 (3.2) | 3 (1.1) | 16 (5.8) |
| Arms (erythema) | 6 (2.2) | 2 (0.7) | 0 | 8 (2.9) |
| Hand (erythema) | 5 (1.8) | 1 (0.4) | 2 (0.7) | 8 (2.9) |
| Face (burning) | 8 (2.9) | 2 (0.7) | 0 | 10 (3.6) |
| Face (burning, other) | 3 (1.1) | 3 (1.1) | 0 | 6 (2.2) |
| Face (dryness, erythema) | 2 (0.7) | 4 (1.4) | 1 (0.4) | 7 (2.5) |
| Face (edema, dryness, pain, erythema, burning, pruritus, other) | 0 | 1 (0.4) | 5 (1.8) | 6 (2.2) |
| Face (erythema) | 9 (3.2) | 7 (2.5) | 0 | 16 (5.8) |
| Face (erythema, burning, other) | 3 (1.1) | 2 (0.7) | 1 (0.4) | 6 (2.2) |
| Face (erythema, other) | 5 (1.8) | 1 (0.4) | 1 (0.4) | 7 (2.5) |
| Face (erythema, pruritus) | 3 (1.1) | 2 (0.7) | 1 (0.4) | 6 (2.2) |
| Face (pain, erythema) | 4 (1.4) | 3 (1.1) | 0 | 7 (2.5) |
| Face (pain, erythema, other) | 3 (1.1) | 3 (1.1) | 0 | 6 (2.2) |
| Face (other) | 5 (1.8) | 4 (1.4) | 0 | 9 (3.2) |
| Special senses | 45 (16.2) | 20 (7.2) | 3 (1.1) | 68 (24.5) |
| Conjunctivitis—eye (burning) | 9 (3.2) | 1 (0.4) | 0 | 10 (3.6) |
| Conjunctivitis—eye (other) | 5 (1.8) | 2 (0.7) | 0 | 7 (2.5) |
| Conjunctivitis—eye (watering) | 10 (3.6) | 10 (3.6) | 1 (0.4) | 21 (7.6) |