TABLE 2

Adverse-event data for randomised controlled trials of targeted therapy in patients with chronic thromboembolic pulmonary hypertension

BENEFIT [39]Sildenafil study [41]CHEST-1 [38]CHEST-2 [40]
BosentanPlaceboSildenafilPlaceboRiociguatPlaceboPrior riociguatPrior placebo
Patients n77809101738815582
All adverse events#
 Headache7122102514
 Dizziness/vertigo5.21.323121920
 Dyspepsia<5<53310188
 Peripheral oedema13816201523
 Nasopharyngitis531592422
 Alanine aminotransferase increase144
 Diarrhoea1051415
 Cough5181315
 Dyspnoea5141211
 Upper respiratory tract infection651210
Serious adverse events+
 Right ventricular failure340033
 Syncope0023
 Haemoptysis00204 (2)
 Worsening pulmonary hypertension3100
 Urticarial rash110
  • 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.