Table 5.
Number, intensity and consequences for trial drug of diarrhea adverse events among patients who experienced ≥ 1 diarrhea adverse event in the INBUILD trial
| Nintedanib (n = 238) | Placebo (n = 86) | |
|---|---|---|
| Number of diarrhea events | ||
| 1 | 112 (47.1) | 70 (81.4) |
| 2 | 46 (19.3) | 11 (12.8) |
| 3 | 42 (17.6) | 2 (2.3) |
| ≥ 4 | 38 (16.0) | 3 (3.5) |
| Time to onset of first diarrhea event (days) | ||
| ≤ 31 | 114 (47.9) | 41 (47.7) |
| > 31 to ≤ 61 | 22 (9.2) | 13 (15.1) |
| > 61 to ≤ 91 | 21 (8.8) | 6 (7.0) |
| > 91 to ≤ 182 | 35 (14.7) | 8 (9.3) |
| > 182 | 46 (19.3) | 18 (20.9) |
| CTCAE grade of worst diarrhea event | ||
| 1 (mild) | 149 (62.6) | 70 (81.4) |
| 2 (moderate) | 60 (25.2) | 10 (11.6) |
| 3 (severe) | 29 (12.2) | 6 (7.0) |
| ≥ 4 (life-threatening/fatal) | 0 | 0 |
| Worst consequence of diarrhea event for trial druga | ||
| Dose reduction | 59 (24.8) | 3 (3.5) |
| Discontinued trial drug | 21 (8.8) | 1 (1.2) |
| Neither of above | 158 (66.4) | 82 (95.3) |
CTCAE: Common Terminology Criteria for Adverse Events [26]. Adverse events reported between first trial drug intake and 28 days after last trial drug intake are shown. Median exposure to trial drug was 17.4 months in both groups. Data are n (% of patients who had ≥ 1 diarrhea adverse event and in whom additional information was collected)
aDiscontinuation of trial drug was considered the worst consequence, followed by dose reduction