Adverse event | HAIC-LEN-PD1 | Â | LEN-PD1 | Â | P-value | |||
---|---|---|---|---|---|---|---|---|
Any grade | Grade 3–4 |  | Any grade | Grade 3–4 |  | Any grade | Grade 3–4 | |
Neutropenia | 45 (43.7%) | 12 (11.7%) |  | 6 (9.8%) | 1 (1.6%) |  | < 0.001 | 0.014 |
Anaemia | 13 (12.6%) | 2 (1.9%) | Â | 5 (8.2%) | 0 (0.0%) | Â | 0.381 | 0.530 |
Thrombocytopenia | 46 (44.7%) | 17 (16.5%) |  | 8 (13.1%) | 2 (3.3%) |  | < 0.001 | 0.011 |
Fatigue | 43 (41.7%) | 3 (2.9%) | Â | 21 (34.4%) | 2 (3.3%) | Â | 0.353 | 0.895 |
Hypertension | 62 (60.2%) | 9 (8.7%) | Â | 32 (52.5%) | 5 (8.2%) | Â | 0.333 | 0.875 |
Weight loss | 41(39.8%) | 3 (2.9%) | Â | 21 (34.4%) | 2 (3.3%) | Â | 0.492 | 0.895 |
Hypothyroidism | 36 (34.9%) | 3 (2.9%) | Â | 18 (29.5%) | 2 (3.3%) | Â | 0.473 | 0.895 |
Rash | 18 (17.5%) | 5 (4.9%) | Â | 10 (16.4%) | 2 (3.3%) | Â | 0.859 | 0.629 |
Vomiting | 43 (41.7%) | 10 (9.7%) |  | 8 (13.1%) | 1 (1.6%) |  | < 0.001 | 0.046 |
Diarrhea | 15 (14.6%) | 2 (1.9%) | Â | 6 (9.8%) | 1 (1.6%) | Â | 0.472 | 0.889 |
Abdominal pain | 62 (60.2%) | 10 (9.7%) |  | 12 (19.7%) | 2 (3.3%) |  | < 0.001 | 0.213 |
Proteinuria | 21 (20.4%) | 5 (4.9%) | Â | 9 (14.8%) | 2 (3.3%) | Â | 0.367 | 0.629 |
Elevated ALT | 62 (60.2%) | 21(20.4%) |  | 11 (18.0%) | 5 (8.2%) |  | < 0.001 | 0.039 |
Elevated AST | 65 (63.1%) | 21 (20.4%) |  | 12 (19.7%) | 6 (9.8%) |  | < 0.001 | 0.078 |
Hyperbilirubinacemia | 45 (43.7%) | 18 (17.5%) | Â | 15 (24.6%) | 3 (4.9%) | Â | 0.087 | 0.020 |
Hyboalbuminaemia | 42 (40.8%) | 15 (14.6%) | Â | 23 (37.7%) | 5 (6.6%) | Â | 0.697 | 0.229 |
Decreased appetite | 38 (36.9%) | 10 (2.9%) | Â | 20 (32.8%) | 3 (4.9%) | Â | 0.595 | 0.895 |
Elevated creatinine | 18 (17.5%) | 4 (3.9%) | Â | 6 (9.8%) | 1 (1.6%) | Â | 0.181 | 0.419 |
Immune-related hepatitis | 5 (4.9%) | 2 (1.9%) | Â | 2 (3.3%) | 1 (1.6%) | Â | 0.859 | 0.889 |
Immune-related pneumonitis | 3 (2.9%) | 2 (1.9%) | Â | 2 (3.3%) | 0 (0.0%) | Â | 0.629 | 0.530 |
Immune-related dermatitis Immune-related myocarditis | 8 (7.8%) 1 (0.9%) | 2 (1.9%) 0 (0.9%) | Â | 2 (3.3%) 0 (0.0%) | 0 (0.0%) 0 (0.0%) | Â | 0.246 0.440 | 0.530 NA |