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