Nintedanib (n = 332) | Placebo (n = 331) | |
---|---|---|
Patients with ≥ 1 treatment interruption | 128 (38.6) | 41 (12.4) |
Number of treatment interruptions per patient | ||
0 | 204 (61.4) | 290 (87.6) |
1 | 81 (24.4) | 32 (9.7) |
2 | 30 (9.0) | 7 (2.1) |
> 2 | 17 (5.1) | 2 (0.6) |
Total number of treatment interruptions | 197 | 52 |
Time to first treatment interruption (days) | ||
≤ 31 | 21 (6.3) | 8 (2.4) |
> 31 to ≤ 91 | 33 (9.9) | 9 (2.7) |
> 91 to ≤ 182 | 27 (8.1) | 7 (2.1) |
> 182 | 47 (14.2) | 17 (5.1) |
Total duration of treatment interruptions (days), mean (SD) | 25.7 (20.1) | 24.1 (22.0) |
Most frequent reasons for treatment interruption considered related to trial drug, n (%) of interruptionsa | ||
Diarrhea | 73 (37.1) | 5 (9.6) |
ALT increased | 14 (7.1) | 1 (1.9) |
Hepatic function abnormal | 10 (5.1) | 1 (1.9) |
AST increased | 7 (3.6) | 0 |
Vomiting | 7 (3.6) | 1 (1.9) |
Nausea | 6 (3.0) | 1 (1.9) |