Table 4.

Overall summary of TEAEs and DRAEs following a SAD schedule with BI 1358894 in study 1402-0001

	Placebo	BI 1358894								Total receiving BI treatment [N = 48]
	[n = 15]	3 mg fasted [n = 6]	6 mg fasted [n = 6]	10 mg fasted [n = 6]	25 mg fasted [n = 6]	50 mg fasted [n = 6]	100 mg fasted [n = 6]	200 mg fasted [n = 6]	200 mg fed [n = 6]
Any TEAE [n (%)]	3 (20.0)	3 (50.0)	6 (100.0)	0 (0)	2 (33.3)	4 (66.7)	4 (66.7)	3 (50.0)	6 (100.0)	28 (58.3)
Any DRAE [n (%)]	0 (0)	1 (16.7)	3 (50.0)	0 (0)	2 (33.3)	4 (66.7)	4 (66.7)	3 (50.0)	4 (66.7)	21 (43.8)
Nervous system disorders	0 (0)	1 (16.7)	3 (50.0)	0 (0)	2 (33.3)	3 (50.0)	4 (66.7)	3 (50.0)	4 (66.7)	20 (41.7)
Headache	0 (0)	1 (16.7)	2 (33.3)	0 (0)	2 (33.3)	3 (50.0)	3 (50.0)	3 (50.0)	3 (50.0)	17 (35.4)
Dizziness	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)	2 (4.2)
Disturbance in attention	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	1 (2.1)
Head discomfort	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	1 (2.1)
Ear and labyrinth disorders	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.1)
Auditory disorder	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.1)
General disorders and administrative site conditions	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	1 (2.1)
Fatigue	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	1 (2.1)
Musculoskeletal and connective tissue disorders	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)	1 (2.1)
Back pain	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)	1 (2.1)

No severe AEs, SAEs, deaths, AESI or other significant AEs were recorded

AEs adverse events, AESI adverse events of special interest, DRAEs drug-related adverse events, SAEs severe adverse events, SAD single ascending dose, TEAEs treatment-emergent adverse events