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| ID | Type | Description | Link |
|---|---|---|---|
| PCSCVM002566 | Other Identifier | Janssen Research & Development, LLC |
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Participants data who are new users of rivaroxaban, apixaban and dabigatran with prior Non-valvular atrial fibrillation/Venous thromboembolism/Total hip replacement (NVAF/VTE/THR) or Total knee replacement (TKR) in a nationally representative population of insured participants in the United States (US) will be compared pairwise. |
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| Comparator Group | Participants data who are new users of warfarin, apixaban, and dabigatran with prior NVAF/VTE/THR or TKR in a nationally representative population of insured participants in the US will be compared pairwise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct oral anticoagulant (DOACs) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 19-Oct-2010 to 31-Dec-2018 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult women aged 18 years and older who are newly exposed to DOACs or warfarin with greater than or equal to (>=) 183 days of prior continuous database observation between 19-Oct-2010 and 31-Dec-2018 will be assessed for severe uterine bleeding.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen R&D | Titusville | New Jersey | 08560 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33651368 | Derived | Weaver J, Shoaibi A, Truong HQ, Larbi L, Wu S, Wildgoose P, Rao G, Freedman A, Wang L, Yuan Z, Barnathan E. Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA. Drug Saf. 2021 Apr;44(4):479-497. doi: 10.1007/s40264-021-01060-4. Epub 2021 Mar 2. |
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| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | 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. |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |