BENEFIT [39] | Sildenafil study [41] | CHEST-1 [38] | CHEST-2 [40] | |||||
Bosentan | Placebo | Sildenafil | Placebo | Riociguat | Placebo | Prior riociguat | Prior placebo | |
Patients n | 77 | 80 | 9 | 10 | 173 | 88 | 155 | 82 |
All adverse events# | ||||||||
Headache | 7 | 1 | 22 | 10 | 25 | 14 | ||
Dizziness/vertigo | 5.2 | 1.3 | 23 | 12 | 19 | 20 | ||
Dyspepsia | <5 | <5 | 33 | 10 | 18 | 8 | ||
Peripheral oedema | 13 | 8 | 16 | 20 | 15 | 23 | ||
Nasopharyngitis | 5 | 3 | 15 | 9 | 24 | 22 | ||
Alanine aminotransferase increase¶ | 14 | 4 | ||||||
Diarrhoea | 10 | 5 | 14 | 15 | ||||
Cough | 5 | 18 | 13 | 15 | ||||
Dyspnoea | 5 | 14 | 12 | 11 | ||||
Upper respiratory tract infection | 6 | 5 | 12 | 10 | ||||
Serious adverse events+ | ||||||||
Right ventricular failure | 3 | 4 | 0 | 0 | 3 | 3 | ||
Syncope | 0 | 0 | 2 | 3 | ||||
Haemoptysis | 0 | 0 | 2 | 0 | 4 (2) | |||
Worsening pulmonary hypertension | 3 | 1 | 0 | 0 | ||||
Urticarial rash | 11 | 0 |
Data are presented as % of patients (rounded to nearest whole number unless otherwise stated) or n (%). #: adverse events occurring in ≥10% of patients in the active treatment arm in any study; ¶: three times the upper limit of normal; +: “most frequent serious adverse events”, as presented in the respective publications.