The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs (rivaroxaban, apixaban, dabigatran) association with risk of SUB compared with warfarin, and (c) individual DOACs (rivaroxaban, apixaban, dabigatran) associated with risk of SUB compared with other individual DOACs - among women with prior diagnoses for DOAC and warfarin indications (non-valvular atrial fibrillation \[NVAF\], venous thromboembolism \[VTE\], total hip replacement \[THR\] or total knee replacement \[TKR\]).
Study Type
OBSERVATIONAL
Enrollment
961,985
Data of participants newly exposed to individual DOACs that is rivaroxaban, apixaban, dabigatran from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
Data of participants newly exposed to warfarin from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
Janssen R&D
Titusville, New Jersey, United States
Number of Participants with Severe Uterine Bleed
Number of participants with severe uterine bleed during two time-at-risk periods (on-treatment and all observed time post-index) will be reported.
Time frame: From 19-Oct-2010 to 31-Dec-2018
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