Table 3.
Most frequent adverse events (reported irrespective of causality) in the INBUILD trial
| Nintedanib (n = 332) | Placebo (n = 331) | |||
|---|---|---|---|---|
| n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | |
| Diarrhea | 240 (72.3) | 136.4 | 85 (25.7) | 23.0 |
| Nausea | 100 (30.1) | 30.8 | 33 (10.0) | 7.6 |
| Vomiting | 64 (19.3) | 17.3 | 16 (4.8) | 3.5 |
| Abdominal pain | 62 (18.7) | 16.7 | 19 (5.7) | 4.2 |
| Nasopharyngitis | 54 (16.3) | 13.9 | 48 (14.5) | 11.4 |
| Decreased appetite | 54 (16.3) | 14.0 | 23 (6.9) | 5.1 |
| Dyspnea | 52 (15.7) | 12.9 | 57 (17.2) | 13.3 |
| Bronchitis | 48 (14.5) | 12.1 | 64 (19.3) | 15.4 |
| Weight decreased | 49 (14.8) | 12.4 | 18 (5.4) | 3.9 |
| ALT increased | 49 (14.8) | 12.4 | 13 (3.9) | 2.8 |
| AST increased | 43 (13.0) | 10.8 | 13 (3.9) | 2.8 |
| Cough | 40 (12.0) | 9.8 | 51 (15.4) | 12.1 |
| Progression of ILDa | 28 (8.4) | 6.5 | 56 (16.9) | 12.7 |
Data are based on adverse events 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. Adverse events were coded based on single preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) version 22.0, except for abdominal pain, which was based on a group of MedDRA preferred terms. Adverse events with a rate > 10 events per 100 patient-years in either treatment group are shown
ALT alanine aminotransferase, AST aspartate aminotransferase
aBased on MedDRA preferred term “interstitial lung disease”