TABLE 2

Adverse events (AEs)

	Placebo^#		Nintedanib 50 mg twice daily^¶		Nintedanib 100 mg twice daily⁺		Nintedanib 150 mg twice daily^§
	Alone	Added to ongoing pirfenidone	Alone	Added to ongoing pirfenidone	Alone	Added to ongoing pirfenidone	Alone	Added to ongoing pirfenidone
Subjects n	7	5	2	4	4	4	11	13
Any AE	2 (28.6)	2 (40.0)	0	0	3 (75.0)	1 (25.0)	6 (54.5)	9 (69.2)
Serious AEs	0	0	0	0	0	0	1 (9.1)	0
Investigator-defined drug-related AEs	1 (14.3)	1 (20.0)	0	0	1 (25.0)	0	3 (27.3)	7 (53.8)
Most common AEs^ƒ
Vomiting	0	0	0	0	0	0	0	5 (38.5)
Nausea	0	0	0	0	0	0	1 (9.1)	4 (30.8)
Diarrhoea	0	0	0	0	0	0	2 (18.2)	2 (15.4)
Nasopharyngitis	0	0	0	0	1 (25.0)	0	0	2 (15.4)
Abdominal discomfort	0	1 (20.0)	0	0	0	0	1 (9.1)	0
Stomatitis	0	0	0	0	1 (25.0)	0	0	1 (7.7)
Alanine aminotransferase increased^##	0	0	0	0	0	0	2 (18.2)	0
Aspartate aminotransferase increased^##	0	0	0	0	0	0	2 (18.2)	0
AEs leading to discontinuation of study drug	0	0	0	0	0	0	2 (18.2)	2 (15.4)
Transaminases increased	0	0	0	0	0	0	2 (18.2)	1 (7.7)
Vomiting	0	0	0	0	0	0	0	1 (7.7)

Data are presented as n (%) unless otherwise stated. “With pirfenidone” group included all pirfenidone doses. ^#: n=12; ^¶: n=6; ⁺: n=8; ^§: n=24; ^ƒ: reported in two or more patients; ^##: increases were reported based on the judgment of the investigator.