Drug use survey for LIXIANA - Drug use survey for LIXIANA

A total of 2,419 patients were registered. Of 2,406 patients whose case report forms were collected, 2,353 were included in the analysis. Adverse drug reactions occurred in 8.92% (210) of patients. Serious adverse reactions occurred in 0.64% (15) of patients, and all patients recovered or improved. Bleeding events included all bleeding (4.42%, 104 patients), major bleeding (1.10%, 26 patients), clinically relevant non-major bleeding (0.98%, 23 patients), and minor bleeding (2.34%, 55 patients). This survey found no increase of bleeding events in the following group: dosage(15mg or 30mg). All patients recovered or improved. No patients had fatal bleeding events or intracranial bleeding. The incidences of symptomatic VTE was 0.38% (9 patients). Symptomatic VTE included proximal deep vein thrombosis (DVT) (0.08%, 2 patients), distal DVT (0.21%, 5 patients), and pulmonary thromboembolism (0.08%, 2 patients). All patients recovered or improved. Lixiana tablets were shown to be well-tolerated in preventing VTE in patients undergoing lower limb orthopaedic surgery in clinical practice.