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 event10 (83)14 (93)6 (75)
Adverse events occurring in ≥10% of patients in any treatment group
 Dyspepsia04 (27)0
 Headache2 (17)4 (27)2 (25)
 Dizziness2 (17)3 (20)2 (25)
 Abdominal pain02 (13)0
 Anaemia02 (13)1 (13)
 Epistaxis02 (13)0
 Hypotension02 (13)0
 Nasopharyngitis1 (8)2 (13)0
 Palpitations2 (17)2 (13)0
 Peripheral oedema1 (8)2 (13)1 (13)
 Back pain2 (17)1 (7)0
 Face oedema1 (8)1 (7)1 (13)
 Hiccups01 (7)1 (13)
 Hypokalaemia01 (7)1 (13)
 Anxiety1 (8)01 (13)
 Asthenia001 (13)
 Blood potassium decreased001 (13)
 Gastritis001 (13)
 Hypertension001 (13)
 Insomnia1 (8)01 (13)
 Nausea2 (17)01 (13)
 Right ventricular failure001 (13)
 Vomiting2 (17)01 (13)
 Worsening PAH001 (13)
 Chest discomfort2 (17)00
 Dyspnoea2 (17)00
 Pain in extremity2 (17)00
  • CHD, congenital heart disease; PAH, pulmonary arterial hypertension.