TABLE 3.
Complete cohort | Pirfenidone | Nintedanib | |
Type of adverse events | 30 | 14 | 16 |
Photosensitivity | 3 (10) | 3 (21.4) | 0 (0) |
Diarrhoea | 7# (23.3) | 0 (0) | 9# (56.3) |
Liver toxicity | 0 (0) | 0 (0) | 0 (0) |
Bleeding | 0 (0) | 0 (0) | 0 (0) |
Gastrointestinal upset | 4 (13.3) | 1 (7.1) | 3 (18.8) |
Fatigue | 3 (10) | 1 (7.1) | 2 (12.5) |
Death | 5¶ (16.7) | 2 (14.3) | 3 (18.8) |
Management of adverse events | |||
Symptomatic management | 3 (12) | 0 (0) | 5 (31.3) |
Dose reduction | 5 (20) | 1 (7.1) | 4# (25) |
Drug discontinuation | 5 (20) | 3 (21.4) | 2 (12.5) |
Switch to alternative antifibrotic | 4 (16) | 3 (21.4) | 1 (6.3) |
Data are presented as n or n (%). #: one patient switched from pirfenidone to nintedanib experienced diarrhoea which was managed with dose reduction; ¶: death occurred in one patient switched from pirfenidone to nintedanib and in one patient switched from nintedanib to pirfenidone.