Table 2. . Adverse events† of all grades occurring in ≥10% of the patients with adenocarcinoma histology in either treatment arm in the LUME-Lung 1 study.
| Preferred term | Nintedanib plus docetaxel, n (%) | Placebo plus docetaxel, n (%) | ||
|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Any AE | 308 (96.3) | 243 (75.9) | 314 (94.3) | 228 (68.5) |
| Diarrhea | 139 (43.4) | 20 (6.3) | 82 (24.6) | 12 (3.6) |
| Decreased neutrophil count | 131 (40.9) | 116 (36.3) | 135 (40.5) | 116 (34.8) |
| ALT increased | 121 (37.8) | 37 (11.6) | 31 (9.3) | 3 (0.9) |
| Fatigue | 99 (30.9) | 15 (4.7) | 98 (29.4) | 14 (4.2) |
| AST increased | 97 (30.3) | 13 (4.1) | 24 (7.2) | 2 (0.6) |
| Nausea | 91 (28.4) | 3 (0.9) | 59 (17.7) | 2 (0.6) |
| Decreased white blood cell count | 89 (27.8) | 63 (19.7) | 94 (28.2) | 61 (18.3) |
| Decreased appetite | 75 (23.4) | 4 (1.3) | 52 (15.6) | 5 (1.5) |
| Vomiting | 62 (19.4) | 4 (1.3) | 41 (12.3) | 2 (0.6) |
| Alopecia | 56 (17.5) | 1 (0.3) | 68 (20.4) | 0 |
| Dyspnea | 54 (16.9) | 15 (4.7) | 52 (15.6) | 20 (6.0) |
| Neutropenia | 44 (13.8) | 38 (11.9) | 51 (15.3) | 45 (13.5) |
| Cough | 42 (13.1) | 3 (0.9) | 63 (18.9) | 2 (0.6) |
| Pyrexia | 39 (12.2) | 2 (0.6) | 47 (14.1) | 1 (0.3) |
| Stomatitis | 36 (11.3) | 4 (1.3) | 26 (7.8) | 1 (0.3) |
| Decreased hemoglobin | 35 (10.9) | 3 (0.9) | 46 (13.8) | 7 (2.1) |
| Constipation | 22 (6.9) | 0 | 39 (11.7) | 1 (0.3) |
Bold events are AEs for which the frequency of all-grade AEs for nintedanib plus docetaxel was >15% with placebo plus docetaxel.
†Defined according to Common Terminology Criteria for Adverse Events v3.0.
AE: Adverse event; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.
Reproduced with permission from [7] © Elsevier (2014).