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Source: Medicine
Management: Food and Drug Administration (FDA)

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Total 2 results found since Jan 2013.

Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation: A retrospective, observational study
East Asians are reportedly at high risk of anticoagulant-related bleeding; therefore, some physicians prefer to prescribe low-dose direct oral anticoagulants (DOACs). Little is known about the therapeutic effectiveness and safety of off-label reduced-dose apixaban in East Asians with nonvalvular atrial fibrillation (AF). We aimed to investigate the effectiveness and safety of off-label reduced-dose apixaban in Taiwanese patients with nonvalvular AF. This retrospective cohort study enrolled 1073 patients with nonvalvular AF who took apixaban between July 2014 and October 2018 from 4 medical centers in southern Taiwan. Th...
Source: Medicine - June 11, 2021 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research

Chart validation of inpatient ICD-9-CM administrative diagnosis codes for ischemic stroke among IGIV users in the Sentinel Distributed Database
The Sentinel Distributed Database (SDD) is a large database of patient-level medical and prescription records, primarily derived from insurance claims and electronic health records, and is sponsored by the U.S. Food and Drug Administration for drug safety assessments. In this chart validation study, we report on the positive predictive value (PPV) of inpatient ICD-9-CM acute ischemic stroke (AIS) administrative diagnosis codes (433.x1, 434.xx, and 436) in the SDD. As part of an assessment of the risk of thromboembolic adverse events following treatment with intravenous immune globulin (IGIV), charts were obtained for 131 ...
Source: Medicine - December 1, 2017 Category: Internal Medicine Tags: Research Article: Diagnostic Accuracy Study Source Type: research