Table 3.

Serious adverse events

Patients reporting event, n (%)
Event	Riociguat (n=60)	Placebo (n=61)
Any SAE	9 (15.0)	15 (24.6)
Any study drug-related SAE	0	2 (3.3)
Discontinuation of study drug due to SAE	2 (3.3)	7 (11.5)
Angina pectoris	1 (1.7)	1 (1.6)
Atrial fibrillation	1 (1.7)	0
Abdominal pain	1 (1.7)	0
Intestinal pseudo-obstruction	1 (1.7)	0
Inflammation	1 (1.7)	0
Lung infection	1 (1.7)	0
Pneumonia	1 (1.7)	2 (3.3)
RP	1 (1.7)	1 (1.6)
Musculoskeletal discomfort	1 (1.7)	0
Pain in extremity	1 (1.7)	0
Dyspnoea	1 (1.7)	0
Intraductal proliferative breast lesion	1 (1.7)	0
Pericarditis	0	2 (3.3)
Left ventricular failure	0	1 (1.6)
Ventricular tachycardia	0	1 (1.6)
Gastric haemorrhage	0	1 (1.6)
Gastro-oesophageal reflux disease	0	1 (1.6)
Nausea	0	1 (1.6)
Vomiting	0	1 (1.6)
Infected skin ulcer	0	1 (1.6)
Anaemia	0	1 (1.6)
Exposure during pregnancy	0	1 (1.6)
Osteolysis	0	1 (1.6)
Scleroderma	0	1 (1.6)
Acute myeloid leukaemia	0	1 (1.6)
Gastric adenocarcinoma	0	1 (1.6)
Ovarian cancer	0	1 (1.6)
Cerebellar infarction	0	1 (1.6)
Syncope	0	1 (1.6)
Scleroderma renal crisis	0	1 (1.6)
Acute pulmonary oedema	0	1 (1.6)
Skin ulcer	0	1 (1.6)
Surgical/medical prophylaxis	0	1 (1.6)

MedDRA preferred terms are shown.

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