Table 3.
Adverse events of any cause
| Event | Arm A (N = 32) | Arm B (N = 20) | ||
|---|---|---|---|---|
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| Any event | 32 (100) | 12 (37.5) | 20 (100) | 11 (55.0) |
| Event leading to discontinuation of all treatment components | 1 (3.1) | 1 (3.1) | 2 (10.0) | 2 (10.0) |
| Event leading to discontinuation of sintilimab | 4 (12.5) | 3 (9.4) | 2 (10.0) | 2 (10.0) |
| Anemia | 22 (68.8) | 1 (3.1) | 15 (75.0) | 4 (20.0) |
| White blood cell count decreased | 12 (37.5) | 1 (3.1) | 8 (40.0) | 1 (5.0) |
| Alanine aminotransferase increased | 10 (31.3) | 2 (6.3) | 2 (10.0) | 0 |
| Neutrophil count decreased | 8 (25.0) | 2 (6.3) | 6 (30.0) | 1 (5.0) |
| Peripheral neuropathy | 8 (25.0) | 1 (3.1) | 1 (5.0) | 0 |
| Platelet count decreased | 3 (9.4) | 1 (3.1) | 4 (20.0) | 1 (5.0) |
| Immune-mediated pneumonitis | 3 (9.4) | 1 (3.1) | 1 (5.0) | 0 |
| Rash | 2 (6.3) | 0 | 3 (15.0) | 0 |
| Hyperthyroidism | 2 (6.3) | 0 | 0 | 0 |
| Myositis | 2 (6.3) | 1 (3.1) | 0 | 0 |
| Hypothyroidism | 1 (3.1) | 0 | 1 (5.0) | 0 |
| Encephalitis | 0 | 0 | 1 (5.0) | 1 (5.0) |