Table 2.

Safety summary

	ID DSP-7888								SC DSP-7888
	3.5 mg (n = 4)		10.5 mg (n = 3)		17.5 mg (n = 3)		Overall (n = 10)		3.5 mg (n = 9)		10.5 mg (n = 5)		Overall (n = 14)
	Anya	Grade ≥ 3	Anya	Grade ≥ 3	Anya	Grade ≥ 3	Anya	Grade ≥ 3	Anya	Grade ≥ 3	Anya	Grade ≥ 3	Anya	Grade ≥ 3
Any TEAE	4 (100)	3 (75.0)	3 (100)	0	3 (100)	1 (33.3)	10 (100)	4 (40.0)	9 (100)	3 (33.3)	5 (100)	2 (40.0)	14 (100)	5 (35.7)
ISRb	4 (100)	0	3 (100)	0	3 (100)	0	10 (100)	0	3 (33.3)	0	2 (40.0)	0	5 (35.7)	0
Nausea	1 (25.0)	0	1 (33.3)	0	0	0	2 (20.0)	0	3 (33.3)	0	0	0	3 (21.4)	0
Aphasiac	0	0	0	0	0	0	0	0	3 (33.3)	1 (11.1)	1 (20.0)	1 (20.0)	4 (28.6)	2 (14.3)
Hypokalemia	1 (25.0)	0	0	0	0	0	1 (10.0)	0	2 (22.2)	1 (11.1)	1 (20.0)	0	3 (21.4)	1 (7.1)
Serious TEAE	1 (25.0)	1 (25.0)	0	0	1 (33.3)	1 (33.3)	2 (20.0)	2 (20.0)	1 (11.1)	1 (11.1)	1 (20.0)	1 (20.0)	2 (14.3)	2 (14.3)
Treatment-related TEAE	4 (100)	1 (25.0)	3 (100)	0	3 (100)	0	10 (100)	1 (10.0)	4 (44.4)	0	3 (60.0)	0	7 (50.0)	0
TEAE leading to treatment discontinuation	0	0	0	0	0	0	0	0	1d	1d	0	0	1d	1d
TEAE leading to death	0	0	0	0	0	0	0	0	1e (11.1)	1e (11.1)	1f (20.0)	1f (20.0)	2 (14.3)	2 (14.3)

Data are n (%). TEAEs were coded to the Medical Dictionary for Regulatory Activities (version 19.1)

ID intradermal, ISR injection-site reaction, SC subcutaneous, TEAE treatment-emergent adverse event

^aPreferred terms reported in > 3 patients are presented

^bThis is a grouping comprising the preferred terms ISR, injection-site erythema, injection-site pain, injection-site pruritus, injection-site hypertrophy, and injection-site induration

^cObserved only in patients with glioblastoma multiforme

^dPatient permanently discontinued DSP-7888 prior to death due to cardio-respiratory arrest

^eSerious TEAE; death due cardio-respiratory arrest

^fThe primary reason for the patient’s death was recorded as disease progression of pancreatic cancer