Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

Table 3 Adverse events in subgroups by age at baseline

	Age < 75 years		Age ≥ 75 years
	Nintedanib (n = 717)	Placebo (n = 647)	Nintedanib (n = 178)	Placebo (n = 148)
Any adverse event(s)	673 (93.9)	540 (83.5)	165 (92.7)	116 (78.4)
Most frequent adverse events^a
Diarrhoea	426 (59.4)	132 (20.4)	108 (60.7)	22 (14.9)
Nausea	171 (23.8)	52 (8.0)	38 (21.3)	12 (8.1)
Decreased appetite	74 (10.3)	24 (3.7)	31 (17.4)	14 (9.5)
Weight decreased	57 (7.9)	12 (1.9)	26 (14.6)	5 (3.4)
Vomiting	79 (11.0)	24 (3.7)	24 (13.5)	1 (0.7)
Nasopharyngitis	84 (11.7)	87 (13.4)	22 (12.4)	15 (10.1)
Cough	90 (12.6)	82 (12.7)	13 (7.3)	18 (12.2)
Progression of IPF^b	57 (7.9)	66 (10.2)	16 (9.0)	12 (8.1)
Serious adverse events^c	174 (24.3)	140 (21.6)	59 (33.1)	40 (27.0)
Fatal adverse events	35 (4.9)	33 (5.1)	5 (2.8)	14 (9.5)
Any adverse event(s) leading to treatment discontinuation	115 (16.0)	70 (10.8)	47 (26.4)	18 (12.2)
Most frequent adverse events leading to treatment discontinuation^d
Diarrhoea	30 (4.2)	1 (0.2)	12 (6.7)	0
Progression of IPF^b	14 (2.0)	28 (4.3)	4 (2.2)	2 (1.4)
Nausea	13 (1.8)	0	6 (3.4)	0
Decreased appetite	8 (1.1)	1 (0.2)	4 (2.2)	1 (0.7)

IPF idiopathic pulmonary fibrosis, MedDRA Medical Dictionary for Regulatory Activities
Adverse events were coded using MedDRA. Data are n (%) of patients with ≥ 1 such event
^aAdverse events reported in > 10% of patients in any of these subgroups are shown
^bCorresponded to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations of IPF
^cEvent that resulted in death, was life-threatening, resulted in hospitalisation or prolonged hospitalisation, resulted in persistent or clinically significant disability or incapacity, was a congenital anomaly or birth defect, or was deemed serious for any other reason
^dAdverse events that led to treatment discontinuation in > 2% of patients in any of these subgroups are shown