Table 2.

Adverse events in Asian patients in the INPULSIS® and INPULSIS®‐ON trials

	INPULSIS®		INPULSIS®‐ON
	Nintedanib (n = 194)	Placebo (n = 128)	Continued nintedanib (n = 121)	Initiated nintedanib (n = 94)
≥1 Adverse event(s)	181 (93.3)	110 (85.9)	119 (98.3)	94 (100.0)
≥1 Severe adverse event(s)†	43 (22.2)	27 (21.1)	63 (52.1)	46 (48.9)
≥1 Serious adverse event(s)‡	65 (33.5)	37 (28.9)	82 (67.8)	63 (67.0)
≥1 Adverse event(s) leading to permanent drug discontinuation§	42 (21.6)	18 (14.1)	48 (39.7)	43 (45.7)
Progression of IPF¶	5 (2.6)	12 (9.4)	13 (10.7)	15 (16.0)
Decreased appetite	6 (3.1)	1 (0.8)	2 (1.7)	1 (1.1)
Diarrhoea	4 (2.1)	0	4 (3.3)	3 (3.2)
Pneumonia	2 (1.0)	1 (0.8)	1 (0.8)	2 (2.1)
Respiratory failure	0	0	4 (3.3)	0
Weight decreased	0	0	3 (2.5)	0
Lung neoplasm malignant	0	1 (0.8)	2 (1.7)	0
Lung infection	0	0	1 (0.8)	3 (3.2)
Dyspnoea	0	0	1 (0.8)	2 (2.1)
FVC decreased	0	0	1 (0.8)	2 (2.1)

Data are n (%) of patients.

^† An event that was incapacitating or that caused an inability to work or to perform usual activities.

^‡ An event that resulted in death, was immediately life‐threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalization, was related to a congenital anomaly or birth defect or was deemed serious for any other reason.

^§ Adverse events leading to permanent drug discontinuation in >1.5% of patients in any group shown by the preferred term in MedDRA.

^¶ Corresponds to MedDRA term ‘IPF’, which included disease worsening and IPF exacerbations.

FVC, forced vital capacity; IPF, idiopathic pulmonary fibrosis; MedDRA, Medical Dictionary for Regulatory Activities.