Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study

Table 4 Incidence of AEs reported during the study

	Period 1 (24 h), N = 20	Period 2 (36 h), N = 20	Period 3 + follow-up (up to 37 days), N = 20
Administration route	Oral	IV infusion	Oral
Patients with ≥ 1 AE	2 (10.0)	10 (50.0)	8 (40.0)
Patients with ≥ 1 SAE	0	0	2 (10.0)
Patients with an AE leading to discontinuation	0	0	0
Patients with ≥ 1 IV selexipag-related AE	N/A	7 (35.0)^a	2 (10.0)^b
Patients with ≥ 1 prostacyclin-associated AE	0	7 (35.0)^a	1 (5.0)^c
Patients with ≥ 1 AE related to infusion site reactions	N/A	2 (10.0)	0
Patients with prostacyclin-associated AE leading to discontinuation	0	0	0
Deaths	0	0	0

Data are n (%)
AE, adverse event; IV, intravenous; SAE, serious adverse event
^aSix patients experienced both IV selexipag-related and prostacyclin-related AEs during Period 2
^bOne patient experienced IV selexipag-related AEs during both Period 2 and Period 3, the other patient experienced IV selexipag-related AEs during Period 3 only
^cThis patient also experienced prostacyclin-associated AEs during Period 2

ISSN: 1465-993X