Exposure–safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease

BMC Pulmonary Medicine

Table 3 Patients with on-treatment diarrhea events of any severity and elevations in liver enzymes over 52 weeks in nintedanib trials TOMORROW, INPULSIS, SENSCIS and INBUILD

Trials (population)	Treatment group	Diarrhea, n (%)	Liver enzyme elevations, n (%)^a
TOMORROW and INPULSIS-1/2 (IPF)	Placebo	91 (18)	3 (1)
	Nintedanib 50 mg BID	17 (20)	2 (2)
	Nintedanib 100 mg BID	32 (37)	0 (0)
	Nintedanib 150 mg BID	445 (62)	36 (5)
SENSCIS (SSc-ILD)	Placebo	91 (32)	2 (1)
SENSCIS (SSc-ILD)	Nintedanib 150 mg BID	218 (76)	14 (5)
INBUILD (progressive fibrosing ILD other than IPF)	Placebo	79 (24)	6 (2) 4 (1)^a
INBUILD (progressive fibrosing ILD other than IPF)	Nintedanib 150 mg BID	221 (67)	43 (13) 26 (8)^a
All		1194 (45)	106 (4) *87 (3)*^a

The bold signifies the total amount
ALT alanine transaminase, AST aspartate transaminase, BID twice daily, ILD interstitial lung disease, IPF idiopathic pulmonary fibrosis, SSc systemic sclerosis
^aFor the INBUILD study, liver enzyme elevations are given based on the 2014 reference ranges for ALT and AST measurements used for the INBUILD primary analysis. The values according to the 2019 updated reference ranges used for sensitivity analysis (more closely aligned to the reference ranges used in the TOMORROW, INPULSIS and SENSCIS trials) are given in italics (see “Materials and methods” section and Additional file 1: Table S1)

ISSN: 1471-2466