Table 2

Classification and risk of adverse events from RCTs and observational studies (n=324)

Classification	Adverse event	Number	Risk of AE per 1000 neonates	95% CI
Gastrointestinal	Vomiting	12	37	21 to 64
	Feeding intolerance/poor feeding	10	31	16 to 57
	NEC	8	25	12 to 49
	Abdominal tenderness	6	19	8 to 41
	Diarrhoea	4	12	5 to 33
	Other gastrointestinal symptoms	13	40	24 to 68
	Total gastrointestinal AE	53	163	128 to 209
Respiratory	BPD	96	296	251 to 350
	Respiratory distress	1	3	4 to 22
	Total respiratory AE	97	299	253 to 354
CNS	At least grade 3 IVH	29	90	63 to 127
	Abnormal hearing	22	68	45 to 102
	PVL	15	46	28 to 76
	Others	4	12	5 to 33
		74	228	187 to 279
Hepatobiliary	Elevated transaminase	16	49	31 to 80
Cardiovascular	PDA	20	62	40 to 94
Metabolic	Hyperkalaemia	2	6	2 to 25
Others	Sepsis	11	34	19 to 61
	Other infections	96	296	251 to 350
	Allergy	2	6	2 to 25
Total		371

AEs, adverse event; BPD, bronchopulmonary dysplasia; RCT, randomised controlled trials.