Table 2.
Common Adverse Events
| Adverse Event | PROSTVAC-VF (n = 82) |
Control (n = 40) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Injection site reactions | ||||
| Erythema | 48 | 58.5 | 22 | 55.0 |
| Pain | 29 | 35.4 | 14 | 35.0 |
| Swelling | 23 | 28.0 | 5 | 12.5 |
| Pruritus | 17 | 20.7 | 4 | 10.0 |
| Induration | 10 | 12.2 | 6 | 15.0 |
| General disorders | ||||
| Fatigue | 35 | 42.7 | 8 | 20.0 |
| Pyrexia | 15 | 18.3 | 6 | 15.0 |
| Peripheral edema | 11 | 13.4 | 4 | 10.0 |
| Chills | 12 | 14.6 | 1 | 2.5 |
| GI disorders | ||||
| Constipation | 9 | 11.0 | 6 | 15.0 |
| Diarrhea | 7 | 8.5 | 6 | 15.0 |
| Nausea | 17 | 20.7 | 2 | 5.0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 10 | 12.2 | 10 | 25.0 |
| Nervous system disorders | ||||
| Dizziness | 10 | 12.2 | 3 | 7.5 |
NOTE. At each level of patient summarization, a patient is counted only once if the patient reported one or more events. Adverse events are coded according to the Medical Dictionary for Regulatory Activities Version 6.0.
Abbreviation: PROSTVAC-VF, a vaccine containing two recombinant viral vectors (vaccinia and fowlpox) and three immune costimulatory molecules (B7.1, ICAM-1, and LFA3).