Table 3—

Adverse events in the placebo/epoprostenol and bosentan/epoprostenol groups observed for ≥three patients until 28 days after the end of the study (safety population)

Adverse eventPlacebo/epoprostenolBosentan/epoprostenol
Subjects n1122
Pain in jaw10 (91)13 (59)
Diarrhoea3 (27)12 (55)
Flushing5 (45)6 (27)
Headache4 (36)6 (27)
Oedema lower limb1 (9)6 (27)
Limb pain2 (18)5 (23)
Nausea2 (18)4 (18)
Dermatitis1 (9)4 (18)
Cardiac failure2 (18)3 (14)
Upper respiratory tract infection1 (9)3 (14)
Abnormal hepatic function2 (18)2 (9)
Cough1 (9)2 (9)
Dizziness1 (9)2 (9)
Dyspnoea1 (9)2 (9)
Epistaxis1 (9)2 (9)
Myalgia1 (9)2 (9)
Worsening PHT2 (18)1 (5)
  • Data are presented as n (%) of patients

  • PHT: worsening pulmonary hypertension