Number, intensity and consequences of diarrhoea adverse events in patients who experienced ≥1 diarrhoea adverse event in the SENSCIS trial
| Nintedanib (n=218) | Placebo (n=91) | |
| Number of diarrhoea events | ||
| 1 | 107 (49.1) | 54 (59.3) |
| 2 | 46 (21.1) | 21 (23.1) |
| 3 | 24 (11.0) | 4 (4.4) |
| ≥4 | 41 (18.8) | 12 (13.2) |
| Time to first onset of diarrhoea event | ||
| ≤30 days | 113 (51.8) | 49 (53.8) |
| >30 to ≤61 days | 35 (16.1) | 12 (13.2) |
| >61 to ≤91 days | 25 (11.5) | 12 (13.2) |
| >91 to ≤182 days | 28 (12.8) | 3 (3.3) |
| >182 days | 17 (7.8) | 15 (16.5) |
| Intensity of worst event* | ||
| Mild | 108 (49.5) | 61 (67.0) |
| Moderate | 98 (45.0) | 27 (29.7) |
| Severe | 12 (5.5) | 3 (3.3) |
| Outcome of worst event | ||
| Recovered | 202 (92.7) | 86 (94.5) |
| Not yet recovered† | 14 (6.4) | 5 (5.5) |
| Recovered/resolved with sequelae | 1 (0.5) | 0 |
| Unknown | 1 (0.5) | 0 |
| Consequence of worst event for trial drug | ||
| Permanently discontinued | 20 (9.2) | 1 (1.1) |
| Permanent dose reduction | 57 (26.1) | 2 (2.2) |
| Neither of above | 141 (64.7) | 88 (96.7) |
Adverse events reported over 52 weeks (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52). Data are n (% of patients with ≥1 diarrhoea adverse event).
*Mild: awareness of signs or symptoms which are easily tolerated; moderate: enough discomfort to cause interference with usual activity; severe: incapacitating or causing inability to work or to perform the usual activities.
†The patient has not yet returned to his/her previous health status and continues to be followed up.