Adverse events (reported irrespective of causality) in SENSCIS and SENSCIS-ON
| SENSCIS | SENSCIS-ON | |||
| Nintedanib (n=288) | Placebo (n=288) | Continued nintedanib (n=197) | Initiated nintedanib (n=247) | |
| Diarrhoea | 218 (75.7) | 91 (31.6) | 134 (68.0) | 170 (68.8) |
| Nausea | 91 (31.6) | 39 (13.5) | 32 (16.2) | 60 (24.3) |
| Vomiting | 71 (24.7) | 30 (10.4) | 27 (13.7) | 53 (21.5) |
| Skin ulcer | 53 (18.4) | 50 (17.4) | 36 (18.3) | 43 (17.4) |
| Nasopharyngitis | 36 (12.5) | 49 (17.0) | 28 (14.2) | 33 (13.4) |
| Upper respiratory tract infection | 33 (11.5) | 35 (12.2) | 27 (13.7) | 26 (10.5) |
| Cough | 34 (11.8) | 52 (18.1) | 24 (12.2) | 21 (8.5) |
| Weight decreased | 34 (11.8) | 12 (4.2) | 14 (7.1) | 26 (10.5) |
| Abdominal pain | 33 (11.5) | 21 (7.3) | 6 (3.0) | 33 (13.4) |
| Liver test abnormalities | 40 (13.9) | 9 (3.1) | 22 (11.2) | 48 (19.4) |
Adverse events were coded according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA). Adverse events are shown based on single preferred terms except for ‘liver test abnormalities’, which was based on the standardised MedDRA query ‘liver related investigations, signs and symptoms’ (broad definition). Data are n (%) of patients with ≥1 such event reported over 52 weeks (or until 28 days after last drug intake if earlier in SENSCIS or until 7 days after last trial drug intake if earlier in SENSCIS-ON). Events reported in >10% of patients in either group in SENSCIS-ON are shown.