TABLE 2.

Safety summary (safety analysis set, n = 70)

	BAY 1831865							Placebo
	3.5 mg i.v. n = 8	7 mg i.v. n = 8	17 mg i.v. n = 8	35 mg i.v. n = 8	75 mg i.v. n = 8	150 mg i.v. n = 8	150 mg s.c. n = 8	i.v. n = 12	s.c. n = 2
Any TEAE, n (%)	5 (62.5)	7 (87.5)	3 (37.5)	4 (50.0)	4 (50.0)	4 (50.0)	3 (37.5)	4 (33.3)	2 (100.0)
Mild	4 (50.0)	7 (87.5)	3 (37.5)	3 (37.5)	4 (50.0)	3 (37.5)	3 (37.5)	4 (33.3)	2 (100.0)
Moderate	1 (12.5)	0	0	1 (12.5)	0	1 (12.5)	0	0	0
Treatment‐related TEAE, n (%)	0	1 (12.5)	0	1 (12.5)	0	0	1 (12.5)	0	0
Mild	0	1 (12.5)	0	1 (12.5)	0	0	1 (12.5)	0	0
TEAE related to procedures required by protocol	1 (12.5)	1 (12.5)	0	1 (12.5)	0	0	0	0	0
TEAE leading to discontinuation	0	0	0	0	0	0	0	0	0
Serious adverse event, n (%)	0	0	0	0	0	0	0	0	0
TEAE of special interest, a n (%)	0	0	0	0	0	0	0	0	0

Abbreviations: i.v., intravenous; s.c., subcutaneous; TEAE, treatment‐emergent adverse event.

^a Hemorrhage, hypersensitivity and infusion‐ or injection‐related reactions, and antidrug antibodies.