TABLE 4

Tolerability and safety of nintedanib in subgroups by baseline GAP (gender, age, physiology) stage

GAP stage IGAP stage II/III
NintedanibPlaceboNintedanibPlacebo
Subjects n304196334226
Adverse event(s)289 (95.1)177 (90.3)320 (95.8)201 (88.9)
Most frequent adverse event(s)#
 Diarrhoea188 (61.8)34 (17.3)210 (62.9)44 (19.5)
 Nausea79 (26.0)13 (6.6)77 (23.1)15 (6.6)
 Nasopharyngitis46 (15.1)27 (13.8)41 (12.3)41 (18.1)
 Cough43 (14.1)26 (13.3)42 (12.6)31 (13.7)
 Vomiting42 (13.8)5 (2.6)32 (9.6)6 (2.7)
 Decreased appetite23 (7.6)7 (3.6)45 (13.5)17 (7.5)
 Progression of IPF17 (5.6)18 (9.2)47 (14.1)42 (18.6)
 Weight decreased26 (8.6)6 (3.1)36 (10.8)9 (4.0)
 Upper respiratory tract infection23 (7.6)21 (10.7)35 (10.5)21 (9.3)
 Abdominal pain32 (10.5)5 (2.6)24 (7.2)5 (2.2)
 Dyspnoea18 (5.9)23 (11.7)31 (9.3)25 (11.1)
 Bronchitis26 (8.6)24 (12.2)41 (12.3)21 (9.3)
Serious adverse event(s)+60 (19.7)45 (23.0)134 (40.1)81 (35.8)
Fatal adverse event(s)8 (2.6)6 (3.1)29 (8.7)25 (11.1)
Adverse event(s) leading to treatment discontinuation48 (15.8)16 (8.2)75 (22.5)39 (17.3)
Most frequent adverse event(s) leading to treatment
discontinuation§
 Diarrhoea10 (3.3)1 (0.5)18 (5.4)0 (0.0)
 Progression of IPF6 (3.1)0 (0.0)13 (3.9)15 (6.6)
 Nausea7 (2.3)0 (0.0)6 (1.8)0 (0.0)
 Decreased appetite2 (0.7)1 (0.5)7 (2.1)0 (0.0)

Data are presented as n or n (%) of patients treated with at least one dose of study drug with one or more such adverse event. IPF: idiopathic pulmonary fibrosis. #: adverse events reported in >10% of patients in any subgroup; : corresponds to MedDRA (Medical Dictionary for Regulatory Activities) term “IPF”, which included disease worsening and acute exacerbations of IPF; +: an event that resulted in death, was immediately life-threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalisation, was related to a congenital anomaly or birth defect or was deemed serious for any other reason; §: adverse events leading to treatment discontinuation in >2% of patients in any subgroup.