Table 2.
Summary of unsolicited adverse events (UAEs) over a period of 12 months in the safety population.
| PTX-COVID19-B n = 374 |
BNT162b2 n = 191 |
Overall n = 565 |
|
|---|---|---|---|
| Any UAEs, n (%) | 288 (77.0) | 154 (80.6) | 442 (78.2) |
| Treatment-related UAEs n (%) | 25 (6.7) | 19 (9.9) | 44 (7.8) |
| Grade ≥ 3 UAEs, n (%) | 14 (3.7) | 5 (2.6) | 19 (3.4) |
| Treatment-related Grade ≥ 3 UAEs, n (%) | 4 (1.1) | 1 (0.5) | 5 (0.9) |
| Serious UAEs, n (%) | 9 (2.4) | 4 (2.1) | 13 (2.3) |
| Treatment-related serious UAEs, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| UAEs leading to study discontinuation, n (%) | 1 (0.3) | 1 (0.5) | 2 (0.4) |
| Medically attended UAEs, n (%) | 25 (6.7) | 8 (4.2) | 33 (5.8) |
| New onset chronic disease, n (%) | 4 (1.1) | 2 (1.0) | 6 (1.1) |
| Adverse event of special interest, n (%) | 1 (0.3) | 1 (0.5) | 2 (0.4) |
| Potentially immune-mediated medical condition, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| UAEs leading to death, n (%) | 0 (0.0) | 1 (0.5) | 1 (0.2) |