Table 4.

Definition of SAEs

The SAEs include but are not limited to

Major bleeding

Bleeding requires transfusion for > 2 units

Severe arrhythmias

Type II second-degree AVB or third-degree AVB

Sustained ventricular tachycardia (> 30 s)

Ventricular fibrillation

Ventilator associated pneumonia, which needs to meet all the criteria below:

At least 48 h after endotracheal intubation

Chest X-ray showing sustained or worsening shadowing (infiltrates or consolidations)

Signs of pulmonary consolidation and/or crackles on auscultation, at least meet one of the following criteria:

a) White blood cell count > 10 × 109/L or < 4 × 109/L

b) Temperature > 37.5 °C, purulent secretions

c) Positive cultures obtained directly from bronchial secretions

Bloodstream infection

Positive cultures obtained from the peripheral blood

SSI

Purulent drainage in the operated region with pain or tenderness, localized swelling, redness, and heat or fever, requiring operation, including superficial incisional wound SSI, deep incisional wound SSI, and organ/space SSI

Limb ischemia from any cause

Physical examination demonstrating pain, pallor, pulseless, cold, and motor or sensor deficit

Requiring decannulation of ECMO catheter or surgical intervention

Stroke

New onset abnormal neurological signs and symptoms last for at least 24 h with radiographic evidence

Any other severe adverse events determined by the physicians

AVB atrioventricular block, ECMO extracorporeal membrane oxygenation, SAE serious adverse events, SSI surgical site infection