Table 1.
Dose reductions in the INBUILD trial
| Nintedanib (n = 332) | Placebo (n = 331) | |
|---|---|---|
| Patients with ≥ 1 dose reduction | 131 (39.5) | 20 (6.0) |
| Number of dose reductions | ||
| 0 | 201 (60.5) | 311 (94.0) |
| 1 | 113 (34.0) | 17 (5.1) |
| 2 | 17 (5.1) | 3 (0.9) |
| > 2 | 1 (0.3) | 0 |
| Total number of dose reductions | 151 | 23 |
| Time to first dose reduction (days) | ||
| ≤ 31 | 18 (5.4) | 3 (0.9) |
| > 31 to ≤ 91 | 30 (9.0) | 10 (3.0) |
| > 91 to ≤ 182 | 36 (10.8) | 3 (0.9) |
| > 182 | 47 (14.2) | 4 (1.2) |
| Most frequent reasons for dose reduction considered related to trial drug, n (%) of dose reductionsa | ||
| Diarrhea | 68 (45.0) | 3 (13.0) |
| ALT increased | 16 (10.6) | 3 (13.0) |
| Hepatic function abnormal | 11 (7.3) | 1 (4.3) |
| Nausea | 10 (6.6) | 2 (8.7) |
| Weight decreased | 7 (4.6) | 0 |
| AST increased | 6 (4.0) | 0 |
| Vomiting | 6 (4.0) | 1 (4.3) |
| Decreased appetite | 4 (2.6) | 1 (4.3) |
| Blood alkaline phosphatase increased | 3 (2.0) | 0 |
| Liver function test increased | 3 (2.0) | 0 |
Data are n (%) of patients unless otherwise stated. Adverse events shown were reported between first trial drug intake and 28 days after last trial drug intake. Median exposure to trial drug was 17.4 months in both groups
ALT alanine aminotransferase, AST aspartate aminotransferase
aAdverse events were coded based on preferred terms in the Medical Dictionary for Regulatory Activities version 22.0. Adverse events that led to > 2 dose reductions in either treatment group are shown. Percentages are based on the total number of dose reductions