Bleeding events (on treatment plus 2 days) versus warfarin in ROCKET AF*
- Similar major bleeding†
- ICH and fatal bleeding rates
- GI bleeding with no difference in fatal GI bleeding
◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.
*Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment (on-treatment period).
†Major bleeding was defined as clinically overt bleeding associated with hemoglobin decrease ≥2 g/dL, transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with fatal outcomes (ISTH criteria).
‡Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.
§Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid, and/or epidural hematoma.
llHemorrhagic stroke in this table specifically refers to nontraumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days.
¶Gl bleeding events included upper GI, lower GI, and rectal bleeding.
#Fatal bleeding is adjudicated death with the primary cause of death from bleeding.
**Major bleeding defined using the validated Cunningham algorithm.
AF = atrial fibrillation; BMI = body mass index; CrCl = creatinine clearance; GI = gastrointestinal; ICH = intracranial hemorrhage; INR = international normalized ratio; ISTH = International Society on Thrombosis and Haemostasis; N/A = not applicable; NVAF = nonvalvular atrial fibrillation; OR = odds ratio; SE = systemic embolism; VTE = venous thromboembolism.