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| ID | Type | Description | Link |
|---|---|---|---|
| APIXABAN SECOND LINE | Other Identifier | Alias Study Number |
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To describe the direct costs related to warfarin/apixaban treatment
To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-valvular Atrial Fibrillation (NVAF) on warfarin | The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention. | ||
| Non-valvular Atrial Fibrillation (NVAF) on apixaban | The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention. |
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| Measure | Description | Time Frame |
|---|---|---|
| CHA2-DS2-VASc Score at Baseline | CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke. | Baseline (from retrospective data retrieved in the study) |
| HAS-BLED Score at Baseline | HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed. | Baseline (from retrospective data retrieved in the study) |
| CHA2-DS2-VASc Score at Month 6 | CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke. | Month 6 (from retrospective data retrieved in the study) |
| HAS-BLED Score at Month 6 | HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed. |
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Inclusion Criteria:
Exclusion Criteria:
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NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultnà nemocnice Motol | Prague | 150 06 | Czechia |
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| 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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Data from eligible participants with non-valvular atrial fibrillation (NVAF) who started treatment with warfarin or apixaban for the prevention of a secondary stroke or transient ischemic attack (TIA) between 2009 to 2019 were observed in this study. Participants' records were retrieved and observed only for first 6 months of the warfarin/apixaban treatment. Collected data from all the participants were observed approximately for 10 months in this observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. |
| FG001 | Warfarin | Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. |
| BG001 | Warfarin |
| 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 | CHA2-DS2-VASc Score at Baseline | CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (from retrospective data retrieved in the study) |
|
6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this 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 | Apixaban | Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | General disorders | Systematic Assessment |
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| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 | May 5, 2022 | Prot_SAP_000.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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| Month 6 (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Outpatient Visits During First 6 Months of Treatment | Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna [CZK] per visit). Costs were calculated based on the number of outpatient visits during the treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of INR Measurements During First 6 Months of Treatment | INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Dosage of Warfarin and Apixaban at the Initiation of the Treatment | In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported. | Baseline (from retrospective data retrieved in the study) |
| Dosage of Warfarin and Apixaban During First 6 Months of Treatment | In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Medication During First 6 Months of Treatment | In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Number of Hospital Admissions | In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Hospital Admissions During First 6 Months of Treatment | In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day). | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Number of Diagnostic Procedures | In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Ischemic Events During First 6 Months of Treatment | Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Major Hemorrhagic Events During First 6 Months of Treatment | Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Minor Hemorrhagic Events During First 6 Months of Treatment | Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Number of Participants With Other Adverse Events During First 6 Months of Treatment | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Cost of Other Adverse Events During First 6 Months of Treatment | Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
| Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment | In this outcome measure, percentage of participants who died due to the given treatment were reported. | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
| BG002 | 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 |
|
| Body-Mass Index (BMI) | Mean | Standard Deviation | Kilogram per meter square (kg/m^2) |
|
| Duration from index event to the initiation of non-vitamin K antagonist anticoagulant therapy (NOAC) | The index event was the first stroke/TIA event based on which the NOAC treatment was initiated. | Mean | Standard Deviation | Days |
|
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy | Count of Participants | Participants |
|
| OG001 | Warfarin | Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. |
|
|
| Primary | HAS-BLED Score at Baseline | HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (from retrospective data retrieved in the study) |
|
|
|
| Primary | CHA2-DS2-VASc Score at Month 6 | CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 (from retrospective data retrieved in the study) |
|
|
|
| Primary | HAS-BLED Score at Month 6 | HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Outpatient Visits During First 6 Months of Treatment | Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna [CZK] per visit). Costs were calculated based on the number of outpatient visits during the treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of INR Measurements During First 6 Months of Treatment | INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Dosage of Warfarin and Apixaban at the Initiation of the Treatment | In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Milligrams per day | Baseline (from retrospective data retrieved in the study) |
|
|
|
| Primary | Dosage of Warfarin and Apixaban During First 6 Months of Treatment | In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Milligrams per day | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Medication During First 6 Months of Treatment | In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized According to Number of Hospital Admissions | In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Hospital Admissions During First 6 Months of Treatment | In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day). | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized According to Number of Diagnostic Procedures | In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures. | Data collected by trial sites for diagnostic procedures were incorrect, hence data was not evaluated and analyzed for this outcome measure. | Posted | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
| Primary | Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Ischemic Events During First 6 Months of Treatment | Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Major Hemorrhagic Events During First 6 Months of Treatment | Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Minor Hemorrhagic Events During First 6 Months of Treatment | Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Number of Participants With Other Adverse Events During First 6 Months of Treatment | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Count of Participants | Participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Cost of Other Adverse Events During First 6 Months of Treatment | Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Mean | Standard Deviation | Czech koruna | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| Primary | Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment | In this outcome measure, percentage of participants who died due to the given treatment were reported. | PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria. | Posted | Number | Percentage of participants | Up to first 6 months of treatment (from retrospective data retrieved in the study) |
|
|
|
| 0 |
| 42 |
| 2 |
| 42 |
| 4 |
| 42 |
| EG001 | Warfarin | Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. | 1 | 67 | 10 | 67 | 0 | 67 |
| Stroke/TIA | General disorders | Systematic Assessment |
|
| Intracranial bleeding | General disorders | Systematic Assessment |
|
| GI bleeding | General disorders | Systematic Assessment |
|
| Intraparenchymal hematoma of the lower lobe | General disorders | Systematic Assessment |
|
| Diarrhoea | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Muscle hematomas | General disorders | Systematic Assessment |
|
| Feeling sick | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
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 |
| 2 visits |
|
| 3 visits |
|
| 4 visits |
|
| 5 visits |
|
| 10 to 19 |
|
| >=20 |
|
| 2 |
|
| 3 |
|
| Muscle hematomas |
|
| Other- Intraparenchymal hematoma of the lower lobe |
|