Table 5.

Summary of adverse events with a fatal outcome.

Body System EventEpoprostenol, N = 97
No. of subjects with ≥ 1 adverse events (%)44 (45)
Cardiovascular system (%)
  Any event27* (28)
  Right-heart failure21 (22)
  Hypotension3 (3)
  Bradycardia1 (1)
  Heart arrest1 (1)
  Shock1 (1)
  Vasculitis1 (1)
Respiratory system (%)
  Any event7 (7)
  Lung disorder3 (3)
  Respiratory disorder3 (3)
  Dyspnea1 (1)
Body as a whole (%)
  Any event6 (6)
  Reaction unevaluable2 (2)
  Sepsis2 (2)
  Sudden death2 (2)
Urinogenital system (%)
  Any event2 (2)
  Kidney failure2 (2)
Digestive system (%)
  Any event1 (1)
  Hemorrhage gastrointestinal1 (1)
Metabolic and nutritional disorder (%)
  Any event1 (1)
  Hyperkalemia1 (1)
  • * One subject had more than one adverse event.