TABLE 2.
Summary of treatment‐emergent adverse events occurring in at least 10% of participants
| AE | Placebo (n = 8) | 40/40/40 μg UB‐312 (n = 6) | 100/100/100 μg UB‐312 (n = 6) | 40/300/300 μg UB‐312 (n = 6) | 300/300/300 μg UB‐312 (n = 6) | 40/1000 μg UB‐312 (n = 6) | 1000/1000 μg UB‐312 (n = 6) | 2000 μg UB‐312 (n = 6) |
|---|---|---|---|---|---|---|---|---|
| Any TEAE, n (%) | 8 (100.0) | 5 (83.3) | 6 (100.0) | 5 (83.3) | 6 (100.0) | 6 (100.0) | 6 (100.0) | 5 (83.3) |
| TEAEs in >10% of participants, n (%) | ||||||||
| Headache | 5 (62.5) | 2 (33.3) | 3 (50.0) | 3 (50.0) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 3 (50.0) |
| Nasopharyngitis | 5 (62.5) | 1 (16.7) | 4 (66.7) | 2 (33.3) | 2 (33.3) | 3 (50.0) | 1 (16.7) | 2 (33.3) |
| Vaccination‐site pain | 2 (25.0) | 3 (50.0) | 1 (16.7) | 0 (0) | 4 (66.7) | 2 (33.3) | 2 (33.3) | 2 (33.3) |
| Lumbar puncture‐site pain | 2 (25.0) | 3 (50.0) | 1 (16.7) | 0 (0) | 1 (16.7) | 0 (0) | 3 (50.0) | 3 (50.0) |
| Fatigue | 1 (12.5) | 0 (0) | 0 (0) | 3 (50.0) | 2 (33.3) | 0 (0) | 2 (33.3) | 0 (0) |
Percentage is based on the number of subjects within the category in the column heading. Classifications are based on Medical Dictionary for Regulatory Activities (MedDRA) version 21.1.
TEAE, treatment‐emergent adverse event.