Table 2.
Outcome definition
| Side event | Definition |
|---|---|
| Vascular disorders | (1) Vascular thrombosis including venous and arterial thrombosis; (2) vasculitis |
| Arhythmia | (1) PSVT; (2) VT; (3) atrial fibrillation; (4) ventricular fibrillation |
| Central nervous disorders | (1) dizzy; (2) headache |
| Diarrhoea | Noninfectious diarrhoea |
| Infection | (1) Noninjection site infection; (2) respiratory system infection; (3) urinary system infection; (4) biliary tract; (5) digestive tract and spontaneous peritonitis |
| Fever | Transient fever (low-grade, 37.3–38 °℃) within 48 h |
| Administration site conditions | (1) Injection site bleeding; (2) injection site swelling; (3) injection site pain; (4) injection site itchy; (5) injection site infection |
| Anaemia | Defined by Hb < 110 g/L |
| Metabolism and nutrition disorders | Mainly refer to malnutrition |
PSVT paroxysmal supraventricular tachycardia, VT ventricular tachycardia