Summary of common treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation (safety population#)
| Patients with at least one TEAE¶ | Patients with at least one TEAE related to pirfenidone only+ | Patients with at least one TEAE related to nintedanib only+ | Patients with at least one TEAE related to both pirfenidone and nintedanib+ | |
| TEAEs occurring in ≥5% of patients | ||||
| ≥1 TEAE | 88 (99) | |||
| ≥1 treatment-related TEAE | 74 (83) | 15 (17) | 67 (75) | 26 (29) |
| Diarrhoea | 44 (49) | 2 (2) | 38 (43) | 5 (6) |
| Nausea | 41 (46) | 3 (3) | 31 (35) | 12 (14) |
| Vomiting | 21 (24) | 1 (1) | 16 (18) | 7 (8) |
| Decreased appetite | 14 (16) | 2 (2) | 7 (8) | 5 (6) |
| Fatigue | 11 (12) | 0 | 8 (9) | 3 (3) |
| Dyspepsia | 8 (9) | 1 (1) | 6 (7) | 1 (1) |
| Headache | 8 (9) | 0 | 7 (8) | 1 (1) |
| Weight decreased | 6 (7) | 1 (1) | 3 (3) | 2 (2) |
| Photosensitivity or rash TEAEs | 7 (8) | 4 (5) | 2 (2) | 1 (1) |
| Abdominal pain upper | 5 (6) | 1 (1) | 2 (2) | 2 (2) |
| Dizziness | 5 (6) | 0 | 4 (5) | 1 (1) |
| TEAEs leading to discontinuation | ||||
| ≥1 TEAE | 13 (15) | |||
| ≥1 treatment-related TEAE | 11 (12) | 0 | 10 (11) | 1 (1) |
| Nausea | 4 (5) | 0 | 3 (3) | 1 (1) |
| Diarrhoea | 4 (5) | 0 | 3 (3) | 1 (1) |
| Fatigue | 2 (2) | 0 | 2 (2) | 0 |
| Weight decreased | 2 (2) | 0 | 2 (2) | 0 |
| Deep vein thrombosis | 1 (1) | 0 | 1 (1) | 0 |
| Epigastric discomfort | 1 (1) | 0 | 1 (1) | 0 |
| Malaise | 1 (1) | 0 | 1 (1) | 0 |
| Migraine | 1 (1) | 0 | 1 (1) | 0 |
| Vomiting | 1 (1) | 0 | 1 (1) | 0 |
Data are presented as n (%). #: n=89; ¶: each of the patients could have experienced one or more treatment-related TEAE, with the potential for different events to be related to different treatments; +: assessed by investigators for each therapy using their previous experience with pirfenidone and/or nintedanib, knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes.