Gastrointestinal and weight loss adverse events by predisposition to intestinal events in the SENSCIS trial
| With predisposition to intestinal events | Without predisposition to intestinal events | |||
| Nintedanib (n=115) | Placebo (n=114) | Nintedanib (n=173) | Placebo (n=174) | |
| Diarrhoea | 86 (74.8) | 37 (32.5) | 132 (76.3) | 54 (31.0) |
| Nausea | 38 (33.0) | 19 (16.7) | 53 (30.6) | 20 (11.5) |
| Vomiting | 32 (27.8) | 16 (14.0) | 39 (22.5) | 14 (8.0) |
| Abdominal pain | 13 (11.3) | 5 (4.4) | 20 (11.6) | 16 (9.2) |
| Weight loss | 18 (15.7) | 8 (7.0) | 16 (9.2) | 5 (2.9) |
Predisposition to intestinal events was defined as a history of, and/or presence at baseline of, diarrhoea, bloating, constipation and/or incontinence. Data are n (%) of patients with ≥1 such adverse event reported over 52 weeks (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52). Adverse events shown are those reported in >10% of patients in either the nintedanib or placebo group by single MedDRA preferred terms in the system organ class ‘gastrointestinal disorders’, except for abdominal pain, which was based on a MedDRA high-level term (related preferred terms), and weight loss, which was based on the MedDRA preferred terms ‘weight decreased’ and ‘abnormal loss of weight’.
MedDRA, Medical Dictionary for Regulatory Activities.