Table 4.

Treatment-emergent adverse events in the subgroup of patients with PAH-CHD in Pulmonary Arterial hyperTENsion sGC-stimulator Trial-1

Adverse event, n (%)	Placebo (n=12)	Riociguat 2.5 mg–maximum (n=15)	Riociguat 1.5 mg–maximum (n=8)
Any adverse event	10 (83)	14 (93)	6 (75)
Adverse events occurring in ≥10% of patients in any treatment group
Dyspepsia	0	4 (27)	0
Headache	2 (17)	4 (27)	2 (25)
Dizziness	2 (17)	3 (20)	2 (25)
Abdominal pain	0	2 (13)	0
Anaemia	0	2 (13)	1 (13)
Epistaxis	0	2 (13)	0
Hypotension	0	2 (13)	0
Nasopharyngitis	1 (8)	2 (13)	0
Palpitations	2 (17)	2 (13)	0
Peripheral oedema	1 (8)	2 (13)	1 (13)
Back pain	2 (17)	1 (7)	0
Face oedema	1 (8)	1 (7)	1 (13)
Hiccups	0	1 (7)	1 (13)
Hypokalaemia	0	1 (7)	1 (13)
Anxiety	1 (8)	0	1 (13)
Asthenia	0	0	1 (13)
Blood potassium decreased	0	0	1 (13)
Gastritis	0	0	1 (13)
Hypertension	0	0	1 (13)
Insomnia	1 (8)	0	1 (13)
Nausea	2 (17)	0	1 (13)
Right ventricular failure	0	0	1 (13)
Vomiting	2 (17)	0	1 (13)
Worsening PAH	0	0	1 (13)
Chest discomfort	2 (17)	0	0
Dyspnoea	2 (17)	0	0
Pain in extremity	2 (17)	0	0

CHD, congenital heart disease; PAH, pulmonary arterial hypertension.