Table 5.
Treatment-Emergent Adverse Events (TEAEs) ≥2% by preferred term,comparison of VGX-3100 formulations in the safety population.
| Preferred term | RF +EP (N = 117) % (n) | FF +EP (N = 118) % (n) | Difference in % (RF+RP – FF+EP) | 95% CI for Difference in %a (Miettinen-Nurminen) |
|---|---|---|---|---|
| Anemia | 5.1 (6) | 3.4 (4) | 1.7 | −4.0, 7.8 |
| Nausea | 8.5 (10) | 13.6 (16) | −5.0 | −13.4, 3.2 |
| Fatigue | 26.5 (31) | 32.2 (38) | −5.7 | −17.3, 6.0 |
| Injection site pain | 53.8 (63) | 66.1 (78) | −12.3 | −24.4, 0.3 |
| Injection site pruritus | 11.1 (13) | 15.3 (18) | −4.1 | −13.1, 4.7 |
| Injection site swelling | 4.3 (5) | 5.9 (7) | −1.7 | −8.1, 4.5 |
| Injection site erythema | 3.4 (4) | 3.4 (4) | 0.0 | −5.4, 5.5 |
| Injection site bruising | 2.6 (3) | 4.2 (5) | −1.7 | −7.3, 3.6 |
| Pyrexia | 2.6 (3) | 0 | 2.6 | −0.6, 7.3 |
| Upper respiratory tract infection | 17.9 (21) | 16.1 (19) | 1.8 | −7.9, 11.6 |
| Urinary tract infection | 0.9 (1) | 2.5 (3) | −1.7 | −6.5, 2.4 |
| Blood creatine phosphokinase increased | 4.3 (5) | 1.7 (2) | 2.6 | −2.2, 8.2 |
| Myalgia | 10.3 (12) | 11.9 (14) | −1.6 | −10.0, 6.7 |
| Arthralgia | 6.8 (8) | 12.7 (15) | −5.9 | −14.0, 1.8 |
| Headache | 16.2 (19) | 16.1 (19) | 0.1 | −9.5, 9.7 |
| Dizziness | 0 | 2.5 (3) | −2.5 | −7.2, 0.7 |
RF = refrigerated formulation of VGX-3100; FF = frozen formulation of VGX-3100; EP = electroporation; CI = Confidence Interval; N = Number of subjects in safety population.
n = Number of subjects in a specific category. Percentages are calculated as 100 × (n/N). Adverse events are coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0. If a subject experienced more than one event in a given system organ class, that subject is counted once for that system organ class. If a subject experienced more than one event with a given preferred term, that subject is counted only once for that preferred term.