Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis

Respiratory Research

Table 3 Patients with adverse events in the INPULSIS^® trials

N (%)	Nintedanib	Placebo
N (%)	(n = 638)	(n = 423)
Any adverse event(s)	609 (95.5)	379 (89.6)
Most frequent adverse events^a
Diarrhea	398 (62.4)	78 (18.4)
Nausea	156 (24.5)	28 (6.6)
Nasopharyngitis	87 (13.6)	68 (16.1)
Cough	85 (13.3)	57 (13.5)
Progression of idiopathic pulmonary fibrosis^b	64 (10.0)	61 (14.4)
Bronchitis	67 (10.5)	45 (10.6)
Dyspnea	49 (7.7)	48 (11.3)
Decreased appetite	68 (10.7)	24 (5.7)
Vomiting	74 (11.6)	11 (2.6)
Adverse event(s) leading to permanent dose reduction	101 (15.8)	2 (0.5)
Adverse event(s) leading to permanent treatment discontinuation	123 (19.3)	55 (13.0)
Adverse events that most frequently led to permanent treatment discontinuation^c
Progression of idiopathic pulmonary fibrosis^b	13 (2.0)	21 (5.0)
Diarrhea	28 (4.4)	1 (0.2)
Nausea	13 (2.0)	0 (0.0)
Decreased appetite	9 (1.4)	1 (0.2)
Pneumonia	6 (0.9)	1 (0.2)
Weight decreased	6 (0.9)	1 (0.2)
Abdominal pain	5 (0.8)	1 (0.2)
Vomiting	5 (0.8)	0 (0.0)
Asthenia	4 (0.6)	0 (0.0)
Increased alanine aminotransferase	4 (0.6)	0 (0.0)
Drug-related adverse events (as reported by the investigators)	455 (71.3)	120 (28.4)
Severe adverse events^d	174 (27.3)	99 (23.4)
Serious adverse events^e	194 (30.4)	127 (30.0)
Fatal adverse event(s)	37 (5.8)	31 (7.3)

Based on patients who received ≥1 dose of study medication
^aAdverse events reported in >10 % of patients in either treatment group
^bCorresponds to the MedDRA term ‘IPF’, which included disease worsening and IPF exacerbations
^cAdverse events leading to permanent treatment discontinuation in >0.5 % of patients in either treatment group, by preferred term
^dA severe adverse event was related to intensity and was defined as an event that was incapacitating or that caused an inability to work or to perform usual activities
^eA serious adverse event was defined as any adverse 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

ISSN: 1465-993X