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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 study consisting of patients who underwent primary Heartware ventricular assist device (HVAD) implantation between September 2011 and 31 May 2017, three patients (one male and two females) [ages not stated] were described, who developed gastrointestinal (GI) bleeding on warfarin, dipyridamole and aspirin (n=1), intraventricular haemorrhage with haemorrhagic stroke on unspecified anticoagulation and dipyridamole (n=1) and intraventricular haemorrhage with haemorrhagic stroke on warfarin and dipyridamole (n=1) therapy [routes and duration of treatments to reaction onsets not stated; not all dosages and outcomes stated].
A male patient developed GI bleeding following treatment with warfarin as anticoagulant and dipyridamole and aspirin as antiplatelet therapy. The male...
- Sorensen EN, et al. Individualized antithrombotic therapy in heartware HVAD recipients. ASAIO Journal 65: 29-35, No. 1, Jan 2019. Available from: URL: http://doi.org/10.1097/MAT.0000000000000751 - USA