TABLE 4.

Phase Ic study in patients with idiopathic pulmonary fibrosis: summary of adverse events (AEs)

	Placebo	BI 1015550 18 mg twice daily	Total on treatment
Patients treated	5 (100.0)	10 (100.0)	15 (100.0)
Any AE	5 (100.0)	10 (100.0)	15 (100.0)
Severe AEs	0 (0.0)	1 (10.0)	1 (6.7)
Investigator-defined drug-related AE	3 (60.0)	9 (90.0)	12 (80.0)
AE leading to discontinuation of study drug	0 (0.0)	1 (10.0)	1 (6.7)
Patients with AESI#	0 (0.0)	0 (0.0)	0 (0.0)
Patients with other significant AEs according to ICH E3	0 (0.0)	1 (10.0)	1 (6.7)
Patients with SAEs	0 (0.0)	1 (10.0)	1 (6.7)
Patients requiring or prolonging hospitalisation	0 (0.0)	1 (10.0)	1 (6.7)

Data are presented as n (%). AESI: adverse event of special interest; ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; SAE: serious adverse event. ^#: hepatic injury was defined as an AESI.