An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a prospective, non-interventional multi-centric Dresden NOAC, cohort study of 23 patients, 10 patients (7 men and 3 women) aged 48−79 years were described, who developed fatal traumatic intracerebral haemorrhage, macro-haematuria, gastrointestinal (GI) bleeding, haematemesis, hypermenorrhoea, haemoptysis, rectal bleeding or haemorrhoidal bleeding during an off label administration of rivaroxaban for acute or chronic splanchnic vein thrombosis (SVT). Additionally, two of these patients also developed GI bleeding during apixaban1 [dosages not stated; not all outcomes stated].
Patient 5: The 70-year-old man, who had SVT, initially received treatment with low molecular weight heparins. After five days of the diagnosis, he started receiving oral rivaroxaban. On day 9, he developed...
- Pannach S, et al. Splanchnic vein thrombosis treatment with rivaroxaban-a case series from the prospective dresden noac registry (NCT01588119). Blood 130 (Suppl. 1): Dec 2017. Available from: URL: http://www.bloodjournal.org/content/130/Suppl_1/1109 [abstract] - Germany