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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 single centre, retrospective study (conducted between May 2011 and April 2017) of 64 patients, 12 patients [ages and sexes not stated] were described, who developed bleeding or haematomas following direct-acting oral anticoagulant (DOAC) treatment with apixaban, rivaroxaban or dabigatran etexilate [dabigatran; dosages and duration of treatments to reactions onset not stated; not all outcomes stated].
A patient, who had atrial fibrillation, received DOAC treatment with dabigatran etexilate. Subsequently, the patient developed DOAC-related major bleeding. The patient received an off-label treatment with factor VIII inhibitor bypassing fraction 6.3 units/kg to reverse the effect of anticoagulant.
A patient, who had chronic deep vein thrombosis and pulmonary embolism, received...