Table 2.
Adverse events in all treated patients
| AE, n(%) | n = 30 |
|---|---|
| Any TEAE | 30 (100%) |
| Any TRAE | 30 (100%) |
| 3-4 grade TEAE | 18 (60%) |
| 3-4 grade TRAE | 17 (56.7%) |
| SAE | 6 (20.0%) |
| Treatment-related SAE | 6 (20.0%) |
| Drug withdraw | |
| Chemotherapy-related drug withdraw | 0 (0%) |
| Sintilimab-related drug withdraw | 1 (3.3%) |
| Dose reduction caused by TRAE | 14 (46.7%) |
| Treatment-related death | 0 (0%) |
| Any grade irAE | 12 (40,0%) |
| 3-4 grade TRAE | |
| Thrombocytopenia | 10 (33.3%) |
| Agranulocytosis | 3 (10.0%) |
| leukopenia | 3 (10.0%) |
| Neutropenia | 2 (6.7%) |
| Hypothyroidism* | 2 (6.7%) |
| Anemia | 1 (3.3%) |
| Elevated transaminase | 1 (3.3%) |
| Autoimmune encephalitis* | 1 (3.3%) |
AE adverse event, TEAE treatment-emergent adverse event, TRAE treatment-related adverse event, SAE serious adverse event, irAE immune-related adverse event.
*immune-related adverse event