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The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health claims database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prescribed apixaban |
| ||
| Patients prescribed dabigatran |
| ||
| Patients prescribed rivaroxaban |
| ||
| Patients prescribed warfarin |
| ||
| Patients prescribed antiplatelet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Treatment for NVAF patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. |
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Inclusion criteria:
Exclusion criteria:
Patients meeting any of the following criteria will not be included in the study.
Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis during the 12-month baseline period (Valvular AF / Prosthetic heart valves)
Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period
Medical claims indicating a diagnosis or procedure code of transient AF, or cardiac surgery during the 12-month baseline period (Thyrotoxicosis, Hypertrophic cardiomyopathy, Elective defibrillation, radiofrequency ablation, or left atrial appendage occlusion)
Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)
For the comparison of "NOAC versus NOAC", and "NOAC versus warfarin", patients with any OACs (apixaban, dabigatran, rivaroxaban, or warfarin) in the pre-index period (from 1 year prior to the day before index date)
For the comparison of "NOAC versus aspirin", patients with following medications in the pre-index period (from 1 year prior to the day before index date)
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Patients will be selected from Korean Health Insurance Review & Assessment Service (HIRA) database according to the inclusion/exclusion criteria. Only users of oral anticoagulant or antiplatelet treatment for atrial fibrillation from July 1, 2015 to November 30, 2016 will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35524839 | Derived | Lee MY, Han S, Bang OY, On YK, Jang SW, Han S, Ryu J, Park YJ, Kang S, Suh HS, Kim YH. Drug Utilization Pattern of Oral Anticoagulants in Patients with Atrial Fibrillation: A Nationwide Population-Based Study in Korea. Adv Ther. 2022 Jul;39(7):3112-3130. doi: 10.1007/s12325-022-02151-z. Epub 2022 May 7. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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It is a retrospective, observational study. Index date: first prescription date of study drugs during intake duration. Intake period: between 1-July-2015 to 30-November-2016. Inverse probability of treatment weighted (IPTW) method was used to analyze outcome measures to balance participant's characteristics among reporting arms.
Data was retrieved from Korean Health Insurance Review & Assessment Service (HIRA) database, of participants who were diagnosed with non-valvular atrial fibrillation (NVAF) from 1-January-2007 up to and including index date, who newly initiated non-vitamin K antagonist oral anticoagulants (NOACs), warfarin or used aspirin during intake duration.
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| ID | Title | Description |
|---|---|---|
| FG000 | NOAC - Apixaban | Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016. |
| FG001 | NOAC - Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016. |
| FG002 | NOAC - Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016. |
| FG003 | Warfarin | OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016. |
| FG004 | Aspirin | OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
OACs treatment-naive participants diagnosed with NVAF, initiating warfarin, NOACs (apixaban, dabigatran, rivaroxaban) or aspirin treatment from 1-July-2015 to 30-November-2016.
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| ID | Title | Description |
|---|---|---|
| BG000 | NOAC - Apixaban | Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
Not applicable as safety data was not planned to be collected during the study
Safety data was not planned to be collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOAC - Apixaban | Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016. |
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Data for Aspirin group could not be matched with other treatment groups (because of genuine difference and heterogeneity in their characteristics) using IPTW method. Hence, no data for Aspirin reporting arm is reported in outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2018 | Dec 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2018 | Dec 11, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Dabigatran |
| Drug |
Treatment for NVAF patients |
|
| Rivaroxaban | Drug | Treatment for NVAF patients |
|
| warfarin | Drug | Treatment for NVAF patients |
|
| Antiplatelets | Drug | Treatment for NVAF patients |
|
| Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
| BG001 | NOAC - Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016. |
| BG002 | NOAC - Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016. |
| BG003 | Warfarin | OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016. |
| BG004 | Aspirin | OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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|
|
|
| Primary | Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Primary | Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
|
|
|
|
| Primary | Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| Secondary | Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis | Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. | OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics. | Posted | Number | events per 100 participants-years | Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | NOAC - Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | NOAC - Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Warfarin | OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Aspirin | OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| Male |
|
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.949 | 2-Sided | 95 | 0.839 | 1.073 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.961 | 2-Sided | 95 | 0.854 | 1.082 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.754 | 2-Sided | 95 | 0.597 | 0.953 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.844 | 2-Sided | 95 | 0.685 | 1.040 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.768 | 2-Sided | 95 | 0.684 | 0.862 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.875 | 2-Sided | 95 | 0.786 | 0.975 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.491 | 2-Sided | 95 | 0.337 | 0.715 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.747 | 2-Sided | 95 | 0.548 | 1.018 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.890 | 2-Sided | 95 | 0.647 | 1.225 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.630 | 2-Sided | 95 | 0.447 | 0.888 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.624 | 2-Sided | 95 | 0.544 | 0.715 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.749 | 2-Sided | 95 | 0.588 | 0.954 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.966 | 2-Sided | 95 | 0.848 | 1.100 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.993 | 2-Sided | 95 | 0.877 | 1.125 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.380 | 2-Sided | 95 | 0.203 | 0.711 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.422 | 2-Sided | 95 | 0.247 | 0.722 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.692 | 2-Sided | 95 | 0.342 | 1.402 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.932 | 2-Sided | 95 | 0.498 | 1.747 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 1.046 | 2-Sided | 95 | 0.719 | 1.522 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 1.295 | 2-Sided | 95 | 0.920 | 1.824 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.697 | 2-Sided | 95 | 0.586 | 0.830 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.936 | 2-Sided | 95 | 0.801 | 1.094 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.538 | 2-Sided | 95 | 0.392 | 0.737 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.664 | 2-Sided | 95 | 0.507 | 0.870 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.918 | 2-Sided | 95 | 0.691 | 1.218 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.771 | 2-Sided | 95 | 0.578 | 1.027 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.640 | 2-Sided | 95 | 0.534 | 0.766 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.838 | 2-Sided | 95 | 0.622 | 1.130 | HR evaluated using extended Cox model. | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.802 | 2-Sided | 95 | 0.678 | 0.947 | Superiority |
| Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used. | Hazard Ratio (HR) | 0.882 | 2-Sided | 95 | 0.754 | 1.032 | Superiority |