TABLE 2.

Number (%) of healthy volunteers with treatment‐emergent adverse events during Parts A and B

	BAY 2433334 25 mg OD (n = 9)	BAY 2433334 50 mg OD (n = 9)	BAY 2433334 100 mg OD (n = 9)	Placebo OD (n = 9)	BAY 2433334 25 mg BID (n = 9)	Placebo BID (n = 3)	Total BAY 2433334 (n = 36)	Total placebo (n = 12)
Any adverse event	3 (33.3%)	5 (55.6%)	5 (55.6%)	3 (33.3%)	4 (44.4%)	2 (66.7%)	17 (47.2%)	5 (41.7%)
Most frequently reported adverse events a
Headache	1 (11.1%)	2 (22.2%)	3 (33.3%)	0	1 (11.1%)	1 (33.3%)	7 (19.4%)	1 (8.3%)
Nasopharyngitis	0	1 (11.1%)	0	1 (11.1%)	0	1 (33.3%)	1 (2.8%)	2 (16.7%)
Oropharyngeal pain	0	1 (11.1%)	0	0	1 (11.1%)	0	2 (5.6%)	0
Toothache	1 (11.1%)	1 (11.1%)	0	0	0	0	2 (5.6%)	0
Medical device site urticaria	0	0	1 (11.1%)	0	1 (11.1%)	0	2 (5.6%)	0
Glutamate dehydrogenase increased	0	1 (11.1%)	0	0	1 (11.1%)	0	2 (5.6%)	0
Lipase increased	0	1 (11.1%)	1 (11.1%)	0	0	0	2 (5.6%)	0
Back pain	0	0	1 (11.1%)	0	0	1 (33.3%)	1 (2.8%)	1 (8.3%)
Epistaxis	0	0	0	1 (11.1%)	1 (11.1%)	0	1 (2.8%)	1 (8.3%)
Any study drug‐related adverse event(s)	0	0	2 (22.2%) b	0	0	0	2 (5.6%)	0
Any study procedure‐related adverse event(s)	1 (11.1%)	3 (33.3%)	1 (11.1%)	2 (22.2%)	2 (22.2%)	1 (33.3%)	7 (19.4%)	3 (25.0%)
Any adverse event(s) of special interest	1 (11.1%)	1 (11.1%)	1 (11.1%)	0	1 (11.1%)	0	4 (11.1%)	0
Bleeding	0	0	0	0	0	0	0	0
Investigations	1 (11.1%) c	1 (11.1%) d	1 (11.1%) d	0	1 (11.1%) e	0	4 (11.1%)	0

BID, twice daily; OD, once daily.

^a Treatment‐emergent adverse events reported (by preferred term) in 2 or more volunteers.

^b Headache.

^c Amylase increased.

^d Lipase increased.

^e Glutamate dehydrogenase increased.