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Table 3 All AEs (preferred terms based on MedDRA version 21.0) during oral administration, IV administration, and re-initiation of oral dosing

From: 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

AE

Number of patients who had an AE, n (%)

Period 1 (Oral; 24 h), N = 20

Period 2 (IV; 36 h), N = 20

Period 3 + follow-up (Oral; up to 37 days), N = 20

Patients with at least 1 AE across all periods

15 (75)

Patients with at least 1 AE

2 (10)

10 (50)

8 (40)

Headache

0

4 (20)

1 (5)

Flushing

0

1 (5)

1 (5)

Nausea

0

1 (5)

1 (5)

Infusion site erythema

0

2 (10)

0

Sleep disorder

1 (5)

0

0

Swelling face

1 (5)

0

0

Diarrhea

0

1 (5)

0

Dysgeusia

0

1 (5)

0

Epistaxis

0

1 (5)

0

Flatulence

0

1 (5)

0

Incorrect drug administration rate

0

1 (5)

0

Infusion site swelling

0

1 (5)

0

Lymphadenopathy

0

1 (5)

0

Myalgia

0

1 (5)

0

Nasal congestion

0

1 (5)

0

Pain in jaw

0

1 (5)

0

Tachycardia

0

1 (5)

0

Tension headache

0

1 (5)

0

Vascular access complication

0

1 (5)

0

Vomiting

0

1 (5)

0

Edema peripheral

0

0

2 (10)

Blindness unilateral

0

0

1 (5)

Cough

0

0

1 (5)

Chromaturia

0

0

1 (5)

Dyspnea

0

0

1 (5)

Hypokalemia

0

0

1 (5)

Nasopharyngitis

0

0

1 (5)

Rhegmatogenous retinal detachment

0

0

1 (5)

Right ventricular failure

0

0

1 (5)

Upper respiratory tract infection

0

0

1 (5)

  1. AE adverse event, IV intravenous, MedDRA Medical Dictionary for Regulatory Activities