Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis

BMC Pulmonary Medicine

Table 2 Adverse events in the INPULSIS and INSTAGE trials

	INPULSIS		INSTAGE
	Nintedanib (n = 638)	Placebo (n = 423)	Nintedanib (n = 136)
Adverse events	580 (90.9)	345 (81.6)	127 (93.4)
Most frequent adverse events^a
Diarrhoea	335 (52.5)	68 (16.1)	66 (48.5)
Nausea	145 (22.7)	25 (5.9)	14 (10.3)
Decreased appetite	53 (8.3)	16 (3.8)	23 (16.9)
Nasopharyngitis	62 (9.7)	43 (10.2)	8 (5.9)
Cough	61 (9.6)	35 (8.3)	13 (9.6)
Vomiting	61 (9.6)	11 (2.6)	10 (7.4)
Dyspnoea	30 (4.7)	25 (5.9)	13 (9.6)
Progression of IPF^b	33 (5.2)	34 (8.0)	12 (8.8)
Weight decreased	41 (6.4)	8 (1.9)	12 (8.8)
Abdominal pain	53 (8.3)	6 (1.4)	9 (6.6)
Adverse events leading to treatment discontinuation	90 (14.1)	32 (7.6)	26 (19.1)
Most frequent adverse events leading to treatment discontinuation^c
Diarrhoea	24 (3.8)	0	3 (2.2)
Nausea	12 (1.9)	0	0
Progression of IPF^b	7 (1.1)	12 (2.8)	0

Data are n (%) of patients with ≥1 such event. In INPULSIS, events with onset between the first dose of trial drug and day 195 (or between the first dose and 28 days after the last dose for patients who discontinued trial drug before week 24) were included. In INSTAGE, events with onset between the first dose and up to 28 days after the last dose of trial drug were included. ^aReported in > 8% of patients in any of the groups shown, based on MedDRA preferred terms. ^bCorresponds to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations. ^cReported in > 1.5% of patients in any of the groups shown, based on MedDRA preferred terms

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