Table 3.

List of Expected Serious Adverse Events

Serious adverse event	Estimated incidence [17]
Death	20%
Necrotising enterocolitis (diagnostic radiological/surgical changes)	15%
Intracranial abnormality on cranial ultrasound scan	15%
(paraenchymal haemorrhage or focal white matter injury)
Ventilator dependency (28 days) and/or oxygen dependency (36 weeks CGA)	65%
Patent ductus arteriosus medical or surgical management	25%
Retinal surgery for retinopathy of prematurity	5%
Pulmonary haemorrhage	5%
Infection ( positive blood culture with clinical signs)	65%
Persistent derangement of liver function tests (36 wks CGA)	10%
Serious extravasation injury (permanent scarring and/or/joint deformity)	<5%

CGA: corrected gestational age