| Primary | Time to Diagnose NVAF by Each OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Mean | Standard Deviation | Days | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | | OG002 | NOACs - Apixaban | Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | | OG003 | NOACs - Dabigatran | Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| | Units | Counts |
|---|
| Participants | - OG000459
- OG001950
- OG002405
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00071± 230.8
- OG001324± 712.2
- OG002218± 541.2
- OG003
|
|
| |
| Primary | Number of Participants With Comorbidities | Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | At index date (any time between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Number of Participants With Use of Aspirin at Start OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Number of Participants With Use of Clopidogrel at Start of OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | HAS-BLED Score at Start of OAC Treatment | The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age >65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Mean | Standard Deviation | Units on a scale | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | CHA2DS2-VASc Score at Start of OAC Treatment | The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Mean | Standard Deviation | Units on a scale | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Anemia at Start of OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Number of Participants With Stroke | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Duration of Follow-up in Participants With Stroke | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants According to Type of Stroke | Number of participants with type of stroke classified as either ischemic cerebrovascular event or hemorrhagic cerebrovascular event were reported in this outcome measure. Participants who reported cerebral infarction, stroke: not specified as hemorrhage or infarction in their medical history during the follow-up period were classified under ischemic cerebrovascular event and participants who reported subarachnoid hemorrhage, intracerebral hemorrhage and other nontraumatic intracranial hemorrhage in their medical record were classified under hemorrhagic stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Pulmonary Embolism | The number of participants who had pulmonary embolism were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Duration of Follow-up in Participants With Pulmonary Embolism | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Gastrointestinal Bleeding | The number of participants who had gastrointestinal bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Duration of Follow-up in Participants With Gastrointestinal Bleeding | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Intracranial Bleeding | The number of participants who had intracranial bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Duration of Follow-up in Participants With Intracranial Bleeding | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Deaths | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Duration of Follow-up in Participants Who Died | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
| |
| Primary | Time Under OAC Treatment (Persistence) by Each OAC Treatment | Persistence was defined as the time under each OAC treatment, calculated as the time in days from the index date to the date of discontinuation or change of treatment. Participants were censored at the end of their follow-up period. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Median | Inter-Quartile Range | Days | | From index date until switch of treatment, discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Number of Participants With Other Major Bleeding | The number of participants who had other major bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
|
| Primary | Duration of Follow-up in Participants With Other Major Bleeding | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
|---|
| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Dose of Initial OAC Prescription by Each OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Mean | Standard Deviation | Milligrams | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | | OG002 | NOACs - Apixaban | |
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| Primary | Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Median | Inter-Quartile Range | Doses | | At index date (anytime between 01-January-2013 to 30-June-2018) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | | OG002 | NOACs - Apixaban | |
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| Primary | Number of Participants With Dose Reduction by Each OAC Treatment | Baseline was defined as the time of index date which was defined as the first prescription with any of the oral anticoagulants, that is, participants with NVAF for the first time starting a therapy with any of the NOACs between 01-Jan-2013 and 30-Jun-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From baseline (index date) until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Time to Dose Reduction by Each OAC Treatment | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Days | | From index date until date of dose reduction or until end of follow-up, anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | |
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| Primary | Number of Participants With Treatment Discontinuation | Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Time to Discontinuation | Time to discontinuation was defined as the number of days from the date of index oral anticoagulant prescription to the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Days | | From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Number of Participants According to Reasons for Discontinuation | Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the warfarin group only. | Posted | | Count of Participants | | Participants | | From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. |
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| Primary | Number of Participants Who Switched to Another OAC Treatment | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Time to Switch to Another OAC Treatment | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | Days | | From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Number of Participants According to Reasons for Switching OAC Treatment | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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| Primary | Number of Participants With Concomitant Therapies by OAC Prescription | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Posted | | Count of Participants | | Participants | | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | | | | ID | Title | Description |
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| OG000 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | | OG001 | NOACs - Rivaroxaban | Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. | | OG002 |
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| Primary | Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the NOACs group only. | Posted | | Count of Participants | | Participants | | Up to 6 months prior to index date | | | | ID | Title | Description |
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| OG000 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. |
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