Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial

Table 4 Most frequent adverse events that led to permanent treatment discontinuation in the INBUILD trial

	Nintedanib (n = 332)		Placebo (n = 331)
	n (%)	Rate per 100 patient-years	n (%)	Rate per 100 patient-years
Any adverse event(s) leading to permanent treatment discontinuation	73 (22.0)	17.0	48 (14.5)	10.3
Diarrhea	21 (6.3)	4.8	1 (0.3)	0.2
ALT increased	6 (1.8)	1.4	1 (0.3)	0.2
Drug-induced liver injury	5 (1.5)	1.1	0	0
Progression of ILD^a	3 (0.9)	0.7	12 (3.6)	2.6

Data are based on adverse events reported between first trial drug intake and 28 days after last trial drug intake. Median exposure to trial drug was 17.4 months in both groups. Adverse events were coded based on preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) version 22.0. Adverse events that led to permanent treatment discontinuation with an incidence rate of > 1 event per 100 patient-years in either group are shown
ALT alanine aminotransferase
^aBased on MedDRA preferred term “interstitial lung disease”

ISSN: 1465-993X