Table 1. Treatment-related adverse events.
Camrelizumab plus chemotherapy (n=205) | Chemotherapy alone (n=207) | |||
All grades | Grade ≥3 | All grades | Grade ≥3 | |
Any | 204 (99.5%) | 146 (71.2%) | 199 (96.1%) | 102 (49.3%) |
Hematological toxicities | ||||
Neutrophil count decreased | 148 (72.2%) | 81 (39.5%) | 133 (64.3%) | 64 (30.9%) |
WBC decreased | 146 (71.2%) | 41 (20.0%) | 133 (64.3%) | 30 (14.5%) |
Anemia | 139 (67.8%) | 41 (20.0%) | 125 (60.4%) | 23 (11.1%) |
Platelet count decreased | 97 (47.3%) | 34 (16.6%) | 79 (38.2%) | 24 (11.6%) |
Lymphocyte count decreased | 23 (11.2%) | 9 (4.4%) | 22 (10.6%) | 5 (2.4%) |
Hemoglobin decreased | 20 (9.8%) | 3 (1.5%) | 22 (10.6%) | 2 (1.0%) |
Non-hematological toxicities | ||||
RCCEP | 158 (77.1%) | 4 (2.0%) | 2 (1.0%) | 0 |
AST increased | 96 (46.8%) | 4 (2.0%) | 68 (32.9%) | 2 (1.0%) |
ALT increased | 90 (43.9%) | 10 (4.9%) | 79 (38.2%) | 6 (2.9%) |
Nausea | 75 (36.6%) | 2 (1.0%) | 61 (29.5%) | 2 (1.0%) |
Asthenia | 68 (33.2%) | 7 (3.4%) | 58 (28.0%) | 3 (1.4%) |
Decreased appetite | 66 (32.2%) | 5 (2.4%) | 56 (27.1%) | 5 (2.4%) |
Constipation | 45 (22.0%) | 0 | 35 (16.9%) | 1 (0.5%) |
Vomiting | 44 (21.5%) | 2 (1.0%) | 35 (16.9%) | 4 (1.9%) |
Hepatic function abnormal | 43 (21.0%) | 4 (2.0%) | 32 (15.5%) | 1 (0.5%) |
GGT increased | 39 (19.0%) | 6 (2.9%) | 18 (8.7%) | 1 (0.5%) |
Blood creatinine increased | 32 (15.6%) | 1 (0.5%) | 14 (6.8%) | 1 (0.5%) |
Rash | 29 (14.1%) | 4 (2.0%) | 11 (5.3%) | 0 |
Pruritus | 25 (12.2%) | 1 (0.5%) | 3 (1.4%) | 0 |
Edema peripheral | 24 (11.7%) | 0 | 17 (8.2%) | 0 |
Myelosuppression | 24 (11.7%) | 14 (6.8%) | 10 (4.8%) | 4 (1.9%) |
Blood bilirubin increased | 23 (11.2%) | 2 (1.0%) | 14 (6.8%) | 0 |
Hypothyroidism | 23 (11.2%) | 1 (0.5%) | 0 | 0 |
Data are n (%). Treatment-related adverse events occurring in at least 10% of patients in either group are listed. Safety data for the chemotherapy alone group did not include data from the crossover phase.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferaseRCCEP, reactive cutaneous capillary endothelial proliferation; WBC, white blood cell