Adverse events#

Group 1Group 2
Any adverse event(s)14 (70.0)15 (88.2)
Severe adverse events2 (10.0)0
Investigator-defined drug-related adverse events12 (60.0)7 (41.2)
Adverse events leading to permanent dose reduction of pirfenidone1 (5.0)0
Adverse events leading to discontinuation of nintedanib00
Adverse events leading to discontinuation of pirfenidone3 (15.0)0
Other significant adverse events3 (15.0)0
Serious adverse events00
Adverse events of particular interest
 Diarrhoea+6 (30.0)4 (23.5)
 Nausea+5 (25.0)3 (17.6)
 Vomiting+3 (15.0)2 (11.8)

Data are presented as n or n (%). #: in treated population. : adverse events reported for the on-treatment period. There was one fatal serious adverse event in the post-study period which was not considered to be drug-related. +: the Common Terminology Criteria for Adverse Events grading was assessed for each event.