Table 3.
Treatment-related adverse events.
| Adverse Events | LenHAP (n=108) | BevHAP (n=108) | p for any grade | p for G3-G4 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| any grade | grade1-2 | grade3 | grade4 | any grade | grade1-2 | grade3 | grade4 | |||
| Hypertension | 48 (44.4%) | 32 (29.6%) | 16 (14.8%) | 0 | 46 (42.6%) | 28 (25.9%) | 18 (16.7%) | 0 | 0.74 | 0.71 |
| Fatigue | 57 (52.8%) | 50 (46.3%) | 7 (6.5%) | 0 | 54 (50.0%) | 49 (45.4%) | 5 (4.6%) | 0 | 0.63 | 0.55 |
| Fever | 14 (13.0%) | 10 (9.3%) | 4 (3.7%) | 0 | 14 (13.0%) | 13 (12.1%) | 1 (0.9%) | 0 | 0.61 | 0.37 |
| Sensory neuropathy | 22 (20.4%) | 21 (19.5%) | 1 (0.9%) | 0 | 19 (17.6%) | 19 (17.6%) | 0 | 0 | 0.8 | 1.0 |
| Abdominal pain | 35 (32.4%) | 29 (26.8%) | 6 (5.6%) | 0 | 36 (33.3%) | 31 (28.7%) | 5 (4.6%) | 0 | 0.62 | 0.76 |
| Nausea | 43 (39.8%) | 39 (36.1%) | 4 (3.7%) | 0 | 38 (35.2%) | 35 (32.4%) | 3 (2.8%) | 0 | 0.79 | 1.0 |
| Vomit | 28 (25.9%) | 26 (24.1%) | 2 (1.9%) | 0 | 30 (27.8) | 28 (25.9%) | 2 (1.9%) | 0 | 0.98 | 1.0 |
| Diarrhea | 43 (39.8%) | 33 (30.6%) | 10 (9.3%) | 0 | 32 (29.6%) | 27 (25.0%) | 5 (4.6%) | 0 | 0.32 | 0.18 |
| Hand-foot syndrome | 35 (32.4%) | 27 (25.0%) | 8 (7.4%) | 0 | 4 (3.7%) | 4 (3.7%) | 0 | 0 | <0.001 | 0.007 |
| Neutropenia | 19 (17.6%) | 5 (4.6%) | 9 (8.3%) | 5 (4.6%) | 10 (9.3%) | 2 (1.9%) | 3 (2.8%) | 5 (4.6%) | 0.26 | 0.18 |
| Anemia | 71 (65.7%) | 71 (65.7%) | 0 | 0 | 82 (75.9%) | 82 (75.9%) | 0 | 0 | 0.11 | – |
| Thrombocytopenia | 52 (48.1%) | 44 (40.7%) | 6 (5.6%) | 2 (1.9%) | 48 (44.4%) | 41 (37.9%) | 7 (6.5%) | 0 | 0.10 | 1.0 |
| Elevated ALT | 72 (66.7%) | 68 (63.0%) | 4 (3.7%) | 0 | 70 (64.8%) | 65 (60.2%) | 5 (4.6%) | 0 | 0.38 | 1.0 |
| Elevated AST | 101 (93.5%) | 80 (74.1%) | 20 (18.5%) | 1 (0.9%) | 103 (95.4%) | 83 (76.8%) | 20 (18.5%) | 0 | 0.84 | 1.0 |
| Hyperbilirubinemia | 61 (56.5%) | 60 (55.5%) | 0 | 1 (0.9%) | 59 (54.6%) | 57 (52.8%) | 2 (1.9%) | 0 | 0.71 | 1.0 |
| Elevated CRE | 7 (6.5%) | 7 (6.5%) | 0 | 0 | 10 (9.3%) | 8 (7.4%) | 2 (1.9%) | 0 | 0.51 | 0.50 |
| Urinary protein | 53 (49.1%) | 52 (48.1%) | 1 (0.9%) | 0 | 62 (57.4%) | 57 (52.8%) | 5 (4.6%) | 0 | 0.29 | 0.21 |
| Hypoalbuminemia | 106 (98.1%) | 106 (98.1%) | 0 | 0 | 105 (97.2%) | 105 (97.2%) | 0 | 0 | 0.062 | – |
| Prolonged PT | 7 (6.5%) | 5 (4.6%) | 2 (1.9%) | 0 | 2 (1.9%) | 2 (1.9%) | 0 | 0 | 0.20 | 0.50 |
| Asites | 7 (6.5%) | 6 (5.6%) | 1 (0.9%) | 0 | 5 (4.6%) | 5 (4.6%) | 0 | 0 | 0.89 | 1.0 |
| Upper gastrointestinal bleeding | 1 (0.9%) | 0 | 1 (0.9%) | 0 | 5 (4.6%) | 3 (2.8%) | 2 (1.9%) | 0 | 0.34 | 1.0 |
| Grade 3-4 | 51 (47.2%) | 43 (39.8%) | 0.27 | |||||||
| Serious AE | 5 (4.6%) | 9 (8.3%) | 0.27 | |||||||