Table 3.

Severe adverse events and adverse events during neonatal intensive care.

	Placebo (n = 5)		UC- MSC (n = 7)
	Events: no.	Animals: no. (%)	Events: no.	Animals: no. (%)
Any severe adverse event	1	1 (20)	3	2 (29)
Any non-severe adverse event	31	5 (100)	34	7 (100)
Mean events per animal		6.4		5.3
Severe adverse events
Death	0	0	0	0
Cardiopulmonary resuscitation	0	0	1	1 (14)
Pulmonary hemorrhage	1	1 (20)	2	2 (29)
Adverse events*
Acidosis, severe	1	1 (20)	3	3 (43)
Arrhythmia	1	1 (20)	0	0
Hyperbilirubinemia	1	1 (20)	0	0
Hyperglycemia	0	0	1	1 (14)
Hyperkalemia	1	1 (20)	1	1 (14)
Hypernatremia	0	0	1	1 (14)
Hypoglycemia, severe	3	3 (60)	3	3 (43)
Hypokalemia	4	3 (60)	5	3 (43)
Hyponatremia	4	4 (80)	5	4 (57)
Hypotension requiring at least one catecholamine	4	4 (80)	1	1 (14)
Hypotension requiring hydrocortisone	1	1 (20)	0	0
Macrohematuria	0	0	1	1 (14)
Microhematuria	4	4 (80)	7	7 (100)
Oliguria	4	2 (40)	2	2 (29)
Peripheral arterial occlusion	1	1 (20)	0	0
Positive blood cultures	0	0	1	1 (14)
Proteinuria	1	1 (20)	3	3 (43)
Tachycardia	1	1 (20)	0	0

^*Events were defined as: acidosis, severe—arterial pH below 7.0 after day of life (DOL)1; hyperbilirubinemia—total bilirubin over 300 µmol/L at any time during the clinical course; hyperglycemia—blood glucose over 11.1 mmol/L; hyperkalemia—potassium over 5.5 mmol/L; hypernatremia—sodium over 150 mmol/L; hypoglycemia, severe—glucose below 1.0 mmol/L after DOL1; hypokalemia—potassium below 3.0 mmol/L; hyponatremia—sodium below 130 mmol/L; proteinuria—moderate or large protein by dipstick in at least two tests within 24 hours, regardless of total proteinuria duration; microhematuria—moderate or large blood by dipstick in at least two tests within 24 hours, regardless of total hematuria duration; Oliguria—less than 0.5 mL/kg/hour for at least 4 hours within a 24-hour period after DOL1; tachycardia—heart rate above 220 beats per minute.

No significant (P < .05) differences in overall event frequency or frequency of any specific adverse event were detected by Fisher’s exact test.