TABLE 2.
Summary of adverse events (safety population*)
| Patients, N (%) | PK Cohort (N=17) | Non-PK Cohort (N=83) | Total (N=100) |
|---|---|---|---|
| TEAEs | 5 (29.4) | 16 (19.3) | 21 (21.0) |
| Mild | 3 (17.6) | 15 (18.1) | 18 (18.0) |
| Moderate | 2 (11.8) | 1 (1.2) | 3 (3.0) |
| Severe | 0 | 0 | 0 |
| Treatment-related | 1 (5.9)** | 0 (0) | 1 (1.0) |
| Serious | 0 | 0 | 0 |
| Leading to study discontinuation | 1 (5.9)** | 0 (0) | 1 (1.0) |
| TEAEs occurring in at least two patients | |||
| Contact dermatitis | 1 (5.9) | 2 (2.4) | 3 (3.0) |
| Upper respiratory tract infection | 0 (0) | 3 (3.6) | 3 (3.0) |
| Nasopharyngitis | 0 (0) | 2 (2.4) | 2 (2.0) |
| Streptococcal pharyngitis | 1 (5.9) | 1 (1.2) | 2 (2.0) |
| Deaths | 0 | 0 | 0 |
PK: pharmacokinetic; TEAE: treatment-emergent adverse event
*All patients who received at least one application of the study treatment
**Contact dermatitis, considered by the investigator to be treatment-related, developed on the back 35 days after the first dose