Table 2.

Adverse events in a phase I study of sildenafil in premature infants.

	Cohort 1 (n = 25) Multiple doses	Cohort 2 (n = 9) Single IV dose
		Dose group 0.25 mg/kg (n = 7)	Dose group 0.125 mg/kg (n = 2)
Number of adverse events, N	13a	8b	2c
Participants with ≥ 1 adverse event, N (%)	8 (32)	5 (71)	2 (100)
Participants with ≥ 1 serious adverse event, N (%)	1 (4)	3 (43)	1 (50)
Cardiogenic shock	1 (4)	0	0
Hypotension	0	1 (14)	0
Pneumothorax	0	1 (14)	0
Necrotizing enterocolitis	0	0	1 (50)
Acute respiratory failure	0	1 (14)	0
Participants with drug-related adverse events, N (%)	0	1 (14)d	0
Participants with low blood pressuree, N (%)	N/A	2 (29)	0
Participants with hypotensionf, N (%)	N/A	0	0

IV intravenous, mg milligrams, kg kilograms, MAP mean arterial pressure, PMA postmenstrual age (gestational age + postnatal age).

^aCardiogenic shock, laryngomalacia, pyrexia, otitis media, tracheitis, tracheobronchitis, hypokalemia, agitation (n = 2), polyuria, pneumothorax, rales, respiratory failure.

^bBradycardia, decreased hematocrit, decreased free thyroxine, acute respiratory failure, apnea, pneumothorax, respiratory disorder, hypotension.

^cNecrotizing enterocolitis, decreased oxygen saturation.

^dHypotension.

^eLow blood pressure was defined as MAP < GA in the 0.25 mg/kg dosing group, and MAP < PMA in the 0.125 mg/kg dosing group.

^fHypotension was defined as 2 MAPs < GA in the 0.25 mg/kg dosing group, and 2 MAPs < PMA in the 0.125 mg/kg dosing group.