Table 3.
Treatment-related adverse events
| Events | Benmelstobart + anlotinib + EC group (N = 246) | Anlotinib + EC group (N = 244) | EC alone group (N = 246) | |||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any TRAEs | 246 (100.0) | 229 (93.1) | 243 (99.6) | 230 (94.3) | 245 (99.6) | 214 (87.0) |
| Frequent TRAEs (≥10% incidence) | ||||||
| Neutropenia | 224 (91.1) | 171 (69.5) | 225 (92.2) | 178 (73.0) | 223 (90.7) | 169 (68.7) |
| Leukopenia | 223 (90.7) | 94 (38.2) | 217 (88.9) | 75 (30.7) | 225 (91.5) | 85 (34.6) |
| Thrombocytopenia | 219 (89.0) | 122 (49.6) | 220 (90.2) | 131 (53.7) | 201 (81.7) | 88 (35.8) |
| Anemia | 192 (78.0) | 59 (24.0) | 198 (81.2) | 65 (26.6) | 207 (84.2) | 58 (23.6) |
| Nausea | 99 (40.2) | 1 (0.4) | 107 (43.9) | 2 (0.8) | 108 (43.9) | 0 |
| Hypertension | 77 (31.3) | 38 (15.5) | 66 (27.1) | 29 (11.9) | 18 (7.3) | 4 (1.6) |
| Hypothyroidism | 75 (30.5) | 1 (0.4) | 55 (22.5) | 0 | 13 (5.3) | 0 |
| Anorexia | 68 (27.6) | 5 (2.0) | 77 (31.6) | 3 (1.2) | 60 (24.4) | 1 (0.4) |
| Alanine aminotransferase increased | 68 (27.6) | 2 (0.8) | 64 (26.2) | 2 (0.8) | 73 (29.7) | 5 (2.0) |
| Hypertriglyceridemia | 67 (27.2) | 8 (3.3) | 82 (33.6) | 20 (8.2) | 46 (18.7) | 2 (0.8) |
| Aspartate aminotransferase increased | 66 (26.8) | 3 (1.2) | 62 (25.4) | 3 (1.2) | 60 (24.4) | 1 (0.4) |
| Vomiting | 62 (25.2) | 1 (0.4) | 60 (24.6) | 2 (0.8) | 70 (28.5) | 1 (0.4) |
| Hypoalbuminemia | 60 (24.4) | 0 | 34 (13.9) | 0 | 37 (15.0) | 1 (0.4) |
| Proteinuria | 59 (24.0) | 2 (0.8) | 53 (21.7) | 1 (0.4) | 28 (11.4) | 1 (0.4) |
| Fatigue | 57 (23.2) | 6 (2.4) | 51 (20.9) | 4 (1.6) | 42 (17.1) | 0 |
| Alopecia | 55 (22.4) | 0 | 47 (19.3) | 0 | 44 (17.9) | 1 (0.4) |
| Hypercholesterolemia | 48 (19.5) | 1 (0.4) | 48 (19.7) | 1 (0.4) | 24 (9.8) | 0 |
| Weight loss | 45 (18.3) | 2 (0.8) | 35 (14.3) | 5 (2.1) | 17 (6.9) | 1 (0.4) |
| Diarrhea | 44 (17.9) | 2 (0.8) | 39 (16.0) | 3 (1.2) | 16 (6.5) | 2 (0.8) |
| Hyponatremia | 39 (15.9) | 11 (4.5) | 38 (15.6) | 9 (3.7) | 39 (15.9) | 12 (4.9) |
| Thyroid-stimulating hormone increased | 33 (13.4) | 0 | 41 (16.8) | 0 | 8 (3.3) | 0 |
| Hemoptysis | 33 (13.4) | 3 (1.2) | 30 (12.3) | 3 (1.2) | 18 (7.3) | 2 (0.8) |
| Constipation | 30 (12.2) | 0 | 37 (15.2) | 0 | 39 (15.9) | 0 |
| Hyperuricemia | 30 (12.2) | 0 | 30 (12.3) | 0 | 31 (12.6) | 0 |
| Occult blood positive | 29 (11.8) | 0 | 26 (10.7) | 0 | 17 (6.9) | 2 (0.8) |
| Lymphocyte count decreased | 29 (11.8) | 8 (3.3) | 24 (9.8) | 7 (2.9) | 24 (9.8) | 7 (2.9) |
| Blood bilirubin increased | 29 (11.8) | 2 (0.8) | 20 (8.2) | 3 (1.2) | 17 (6.9) | 2 (0.8) |
| Palmar–plantar erythrodysesthesia syndrome | 28 (11.4) | 6 (2.4) | 22 (9.0) | 8 (3.3) | 3 (1.2) | 0 |
| Gamma-glutamyltransferase increased | 27 (11.0) | 4 (1.6) | 41 (16.8) | 5 (2.1) | 28 (11.4) | 3 (1.2) |
| Fever | 27 (11.0) | 0 | 9 (3.7) | 0 | 10 (4.1) | 0 |
| Hyperthyroidism | 25 (10.2) | 0 | 5 (2.1) | 0 | 6 (2.4) | 0 |
| Alkaline phosphatase increased | 22 (8.9) | 2 (0.8) | 29 (11.9) | 0 | 19 (7.7) | 0 |
Data are n (%).