Table 3.

Overall summary of adverse events by formulation group in the safety population.

Subjects with at least one	RF + EP (N = 117) % (n)	FF + EP (N = 118) % (n)	Total (N = 235) % (n)
Adverse event	78 (91)	82 (97)	80 (188)
Treatment-emergent adverse event (TEAE)	78 (91)	81 (96)	80 (187)
Treatment-relateda treatment-emergent adverse event	62 (72)	73 (86)	67 (158)
Treatment-emergent serious adverse event	3 (3)	1 (1)	2 (4)
Grade 3 or higher treatment-emergent adverse event	7 (8)	3 (4)	5 (12)
TEAE leading to discontinuation of treatment	1 (1)	0 (0)	0.4 (1)
TEAE leading to death	1 (1)	0 (0)	0.4 (1)

RF = refrigerated formulation of VGX-3100; FF = frozen formulation of VGX-3100; EP = electroporation.

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.

^aIncludes events classified as definitely/probably/possibly related to treatment or events with a missing relationship.