Adverse events#
| Group 1 | Group 2 | |
| Subjects | 20 | 17 |
| Any adverse event(s) | 14 (70.0) | 15 (88.2) |
| Severe adverse events | 2 (10.0) | 0 |
| Investigator-defined drug-related adverse events | 12 (60.0) | 7 (41.2) |
| Adverse events leading to permanent dose reduction of pirfenidone | 1 (5.0) | 0 |
| Adverse events leading to discontinuation of nintedanib | 0 | 0 |
| Adverse events leading to discontinuation of pirfenidone | 3 (15.0) | 0 |
| Other significant adverse events | 3 (15.0) | 0 |
| Serious adverse events¶ | 0 | 0 |
| 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) |
| Bleeding | 0 | 0 |
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.