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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective blinded study of 66 patients, four elderly women age ranged 65−80 years were described, who developed pulmonary oedema during treatment with ambrisentan, bosentan, sildenafil or tadalafil [routes not stated; not all dosages stated; duration of treatments to reactions onsets and outcomes not stated].
Patient 1: A 74-year old woman developed pulmonary oedema during treatment with sildenafil and bosentan. The woman with stage III systemic sclerosis pulmonary arterial hypertension (SSc-PAH), received sildenafil and bosentan as pulmonary vasodilator therapy. During vasodilator therapy, a chest CT scan performed, which was unremarkable. However, she had a creatinine of 114 µmol/L, mean pulmonary artery pressure (mPAP) of 45mm Hg, pulmonary capillary wedge pressure...
- Connolly MJ, et al. Prognostic significance of computed tomography criteria for pulmonary veno-occlusive disease in systemic sclerosis-pulmonary arterial hypertension. Rheumatology 56: 2197-2203, No. 12, 1 Dec 2017. Available from: URL: http://doi.org/10.1093/rheumatology/kex351 - United Kingdom