Table 2.

Summary of Adverse Events

Adverse Event	Total		Attributed to Talimogene Laherparepvec		Attributed to Ipilimumab
	Any Grade No. (%)	Grade 3/4 No. (%)	Any Grade No. (%)	Grade 3/4 No. (%)	Any Grade No. (%)	Grade 3/4 No. (%)
Any treatment-related AE	18 (94.7)	5 (26.3)	17 (89.5)	3 (15.8)	15 (78.9)	4 (21.1)
Treatment-related AEs > 10% by preferred term
Chills	11 (57.9)	0	11 (57.9)	0	6 (31.6)	0
Pyrexia	11 (57.9)	1 (5.3)	11 (57.9)	1 (5.3)	7 (36.8)	0
Fatigue	9 (47.4)	1 (5.3)	6 (31.6)	1 (5.3)	8 (42.1)	1 (5.3)
Diarrhea	8 (42.1)	1 (5.3)	6 (31.6)	1 (5.3)	6 (31.6)	1 (5.3)
Pruritus	8 (42.1)	0	6 (31.6)	0	4 (21.1)	0
Rash	8 (42.1)	0	6 (31.6)	0	4 (21.1)	0
Headache	7 (36.8)	0	7 (36.8)	0	6 (31.6)	0
Nausea	7 (36.8)	2 (10.5)	7 (36.8)	1 (5.3)	5 (26.3)	2 (10.5)
Influenza-like illness	3 (15.8)	1 (5.3)	3 (15.8)	1 (5.3)	1 (5.3)	1 (5.3)
Pain	3 (15.8)	0	3 (15.8)	0	2 (10.5)	0
Vision blurred	3 (15.8)	0	2 (10.5)	0	2 (10.5)	0
ALT increased	2 (10.5)	0	1 (5.3)	0	1 (5.3)	0
Back pain	2 (10.5)	0	2 (10.5)	0	1 (5.3)	0
Dehydration	2 (10.5)	1 (5.3)	1 (5.3)	1 (5.3)	2 (10.5)	1 (5.3)
Erythema	2 (10.5)	0	1 (5.3)	0	1 (5.3)	0
Hypokalemia	2 (10.5)	0	2 (10.5)	0	0	0
Injection site reaction	2 (10.5)	0	2 (10.5)	0	0	0
Night sweats	2 (10.5)	0	2 (10.5)	0	1 (5.3)	0
Rash, erythematous	2 (10.5)	0	1 (5.3)	0	1 (5.3)	0
Vomiting	2 (10.5)	1 (5.3)	2 (10.5)	1 (5.3)	2 (10.5)	1 (5.3)
Vulvovaginal mycotic infection	2 (10.5)	0	1 (5.3)	0	1 (5.3)	0

NOTE. AEs of any grade reported in > 10% of patients are shown. AEs were collected during treatment or up to 30 days after the last talimogene laherparepvec administration or 60 days after the last ipilimumab administration, whichever was later. All treatment-related grade 3/4 events were grade 3 events except for two grade 4 treatment-related events of elevated amylase and lipase attributed to ipilimumab occurring in a single patient. One grade 5 AE of metastasis to the central nervous system was reported as unrelated to study treatment.

Abbreviation: AE, adverse event.