TABLE 2.

Overall summary of adverse events

Parameter	PBI-4050 alone	PBI-4050+nintedanib	PBI-4050+pirfenidone
Total patients	9	16	16
Patients with at least one AE	8 (88.9)	12 (75.0)	14 (87.5)
Patients with at least one severe AE	0	1 (6.3)	2 (12.5)
Patients with at least one serious AE	0	1 (6.3)	0
Deaths	0	0	0
AEs leading to permanent discontinuation of study drug	0	0	1 (6.3)
AEs in >2 patients, by preferred term#
Diarrhoea	3 (33.3)	7 (43.8)	6 (37.5)
Nausea	0	0	4 (25.0)
Headache	2 (22.2)	1 (6.3)	1 (6.3)
Fatigue	0	1 (6.3)	2 (12.5)
Non-cardiac chest pain	1 (11.1)	0	2 (12.5)
Cough	0	0	3 (18.8)
Dyspnoea	0	0	3 (18.8)

Data are presented as n or n (%). Patients can be counted in more than one category. AE: adverse event. ^#: Medical Dictionary for Regulatory Activities [21].