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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 prospective, non-interventional multi-centric Dresden NOAC, cohort study of 26 patients, 11 patients (7 men and 4 women) aged 48−79 years were described, who developed skin bleeding, fatal traumatic intracranial haemorrhage, macro-haematuria, gastrointestinal (GI) bleeding, haematemesis, hypermenorrhoea, haemoptysis, rectal bleeding or haemorrhoid bleeding following off label administration of rivaroxaban for acute or chronic splanchnic vein thrombosis (SVT). One of these patients was also receiving vitamin K antagonist [specific drug not stated]. Additionally, two of these patients also developed GI bleeding during apixaban treatment [not all dosages and outcomes stated].
Patient 2: The 51-year-old woman started receiving rivaroxaban for SVT. On day 569, she developed...
- Pannach S, et al. Splanchnic Vein Thrombosis Treatment with Rivaroxaban-A Case Series from the Prospective Dresden NOAC Registry (NCT01588119). Hamostaseologie 38 (Suppl. 1): A17-A18, Jan 2018 [abstract] - GermanyGoogle Scholar