Table 2.
15 μg PD03A (N = 12) | 75 μg PD03A (N = 12) | Placebo (N = 12) | |
Patients with≥1 TEAE; n (%) | 12 (100) | 12 (100) | 12 (100) |
Patients with≥1 serious TEAE; n (%) | 2 (16.7) | 0 | 3 (25.0) |
Patients with any TEAE leading to treatment discontinuation; n | 0 | 0 | 0 |
Patients with≥1 local site reaction; n (%) | 12 (100) | 10 (83.3) | 12 (100) |
Treatment emergent, treatment-related* systemic AEs occurring in ≥1 patient in any group* | |||
Headache; n (%) | 0 | 1 (8.3) | 0 |
Fatigue; n (%) | 0 | 0 | 1 (8.3) |
Myalgia; n (%) | 1 (8.3) | 1 (8.3) | 0 |
*considered probably or certainly related to study treatment.