Table 2– Treatment-emergent and drug-related adverse events experienced by two or more patients during the 12-week treatment or continuation phases of the study
Adverse eventsAdverse event in two or more patientsTreatment-emergent eventsDrug-related treatment-emergent events
Oedema peripheral8 (36.4)8 (36.4)6 (27.3)
Dyspnoea7 (31.8)7 (31.8)6 (27.3)
Dyspepsia5 (22.7)5 (22.7)3 (13.6)
Nasopharyngitis5 (22.7)5 (22.7)0 (0)
Headache4 (18.2)4 (18.2)3 (13.6)
Feeling hot3 (13.6)3 (13.6)3 (13.6)
Bronchitis3 (13.6)3 (13.6)0 (0)
Pancytopenia2 (9.1)2 (9.1)2 (9.1)
Gastroenteritis2 (9.1)2 (9.1)1 (4.5)
Hypoxaemia2 (9.1)2 (9.1)2 (9.1)
Hypotension2 (9.1)2 (9.1)1 (4.5)
Respiratory failure2 (9.1)2 (9.1)1 (4.5)
Right ventricular failure2 (9.1)2 (9.1)1 (4.5)
Respiratory tract infection2 (9.1)2 (9.1)0 (0)
Pulmonary fibrosis2 (9.1)1 (4.5)0 (0)
Diarrhoea2 (9.1)2 (9.1)0 (0)
Total number of patients reporting any event21 (95.5)20 (90.9)15 (68.2)
  • Data are presented as n (%).