Table 3

Serious adverse events

Patients reporting event, n (%)
EventRiociguat (n=60)Placebo (n=61)
Any SAE9 (15.0)15 (24.6)
Any study drug-related SAE02 (3.3)
Discontinuation of study drug due to SAE2 (3.3)7 (11.5)
Angina pectoris1 (1.7)1 (1.6)
Atrial fibrillation1 (1.7)0
Abdominal pain1 (1.7)0
Intestinal pseudo-obstruction1 (1.7)0
Inflammation1 (1.7)0
Lung infection1 (1.7)0
Pneumonia1 (1.7)2 (3.3)
RP1 (1.7)1 (1.6)
Musculoskeletal discomfort1 (1.7)0
Pain in extremity1 (1.7)0
Dyspnoea1 (1.7)0
Intraductal proliferative breast lesion1 (1.7)0
Pericarditis02 (3.3)
Left ventricular failure01 (1.6)
Ventricular tachycardia01 (1.6)
Gastric haemorrhage01 (1.6)
Gastro-oesophageal reflux disease01 (1.6)
Nausea01 (1.6)
Vomiting01 (1.6)
Infected skin ulcer01 (1.6)
Anaemia01 (1.6)
Exposure during pregnancy01 (1.6)
Osteolysis01 (1.6)
Scleroderma01 (1.6)
Acute myeloid leukaemia01 (1.6)
Gastric adenocarcinoma01 (1.6)
Ovarian cancer01 (1.6)
Cerebellar infarction01 (1.6)
Syncope01 (1.6)
Scleroderma renal crisis01 (1.6)
Acute pulmonary oedema01 (1.6)
Skin ulcer01 (1.6)
Surgical/medical prophylaxis01 (1.6)
  • MedDRA preferred terms are shown.

  • MedDRA, Medical Directory for Regulatory Activities; RP, Raynaud’s phenomenon; SAE, serious adverse event.