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| ID | Type | Description | Link |
|---|---|---|---|
| VTE HIRA Study | Other Identifier | Alias Study Number |
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This study is a retrospective, observational, nationwide population-based cohort study utilizing the South Korea's Health Insurance and Review Assessment Service (HIRA) database. The aims of this study are to describe the sociodemographic and clinical characteristics of patients with venous thromboembolism according to their anticoagulant treatment (parenteral anticoagulants, warfarin, or non-vitamin K antagonist oral anticoagulants), to describe the treatment patterns related to anticoagulants, and to examine the risk of major bleeding according to the specific type of oral anticoagulants. The study will be conducted in two phases: Phase I for descriptive study and Phase II for comparative study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral anticoagulant only | LMWH, UFH |
| |
| Warfarin-based | Warfarin only + parenteral anticoagulant bridged warfarin |
| |
| NOAC-based | NOAC only + parenteral anticoagulant bridged NOAC NOAC: apixaban, rivaroxaban, dabigatran, edoxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral anticoagulant | Drug | Parenteral anticoagulant only |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Interruption in Index Anticoagulant Treatment | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Time to Treatment Interruption | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants Who Switched to Another Anticoagulant Therapy | Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Time to Treatment Switch |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with venous thromboembolism from the South Korea's Health Insurance Review and Assessment Service (HIRA) database between Mar 1, 2013 and Jun 30, 2019
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | ||||
| Sungkyunkwan University |
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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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Study was to be conducted in 2 phases. Phase 1: to describe anticoagulant treatment pattern according to index VTE treatment (PAC only, warfarin based, NOAC based treatment). Phase 2: to compare risk of major bleeding according to specific type of OAC treatment. But, as assessed by real world data review committee Phase 2 was not conducted due to insufficient statistical power that would lead to small and imbalanced sample sizes in comparison groups. Only Phase 1 data were studied and reported.
Data of participants diagnosed with venous thromboembolism (VTE) between 1 Mar 2013 and 30 Jun 2019 and received first prescription of anticoagulants within 30 days of VTE diagnosis in real world clinical practice, were retrieved from South Korea's health insurance review and assessment service (HIRA) database. Available data were extracted and evaluated during approximately 1 month of this retrospective observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin-Based Therapy | Participants diagnosed with VTE, initiated warfarin-based therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| FG001 | Non-vitamin K Antagonist Oral Anticoagulants (NOAC)-Based Therapy: Apixaban | Participants diagnosed with VTE, initiated apixaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| FG002 | NOAC-Based Therapy: Dabigatran | Participants diagnosed with VTE, initiated dabigatran (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| FG003 | NOAC-Based Therapy: Edoxaban | Participants diagnosed with VTE, initiated edoxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| FG004 | NOAC-Based Therapy: Rivaroxaban | Participants diagnosed with VTE, initiated rivaroxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| FG005 | Parenteral Anticoagulants (PAC) Only | Participants diagnosed with VTE, initiated PAC only therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin-Based Therapy | Participants diagnosed with VTE, initiated warfarin-based therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG001 | NOAC-Based Therapy: Apixaban |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. |
| 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 | Number of Participants With Interruption in Index Anticoagulant Treatment | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
|
Adverse events were not planned to be collected hence time frame was not applicable
In this study individual participant data was not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) cannot be met. Hence, AEs were not collected and reported 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 | Warfarin-Based Therapy | Participants diagnosed with VTE, initiated warfarin-based therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
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Phase 2 was not conducted due to insufficient statistical power that would lead to small and imbalanced sample sizes in comparison groups.
| 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 | Apr 27, 2022 | Sep 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2022 | Sep 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C522181 | apixaban |
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin |
| Drug |
Warfarin-based |
|
| Apixaban | Drug | Apixaban |
|
| Rivaroxaban | Drug | Rivaroxaban |
|
| Dabigatran | Drug | Dabigatran |
|
| Edoxaban | Drug | Edoxaban |
|
Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
| From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants Who Completely Discontinued Index Anticoagulant Treatment | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Time to Treatment Discontinuation | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Overall Index Anticoagulant Treatment Duration | Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. | Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. | Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. | Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major bleeding" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "complications of VTE" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "thromboembolism" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major surgery" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "cancer-related event" are reported among participants without active cancer. Data not collected and reported for participants with active because all participants already had cancer. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "kidney function change" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "liver function change" are reported. | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. | Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
| Suwon |
| South Korea |
Participants diagnosed with VTE, initiated apixaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG002 | NOAC-Based Therapy: Dabigatran | Participants diagnosed with VTE, initiated dabigatran (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG003 | NOAC-Based Therapy: Edoxaban | Participants diagnosed with VTE, initiated edoxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG004 | NOAC-Based Therapy: Rivaroxaban | Participants diagnosed with VTE, initiated rivaroxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG005 | PAC Only | Participants diagnosed with VTE, initiated PAC only therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| BG006 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of Participants According to Type of Index VTE Event | Index VTE event included Deep Vein Thrombosis (DVT) only, and Pulmonary Embolism (PE) with or without DVT. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Number of Participants With Major Orthopedic Surgery-provoked VTE | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Number of Participants According to Health Insurance Type | In this baseline measure, number of participant with their health insurance type such as national health insurance, medical aid, and veterans were reported. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Number of Participants Classified According to the Index Year | In this baseline measure, number of participants were classified according to the index year in which they started receiving anticoagulants. Index year was defined as the year in which the treatment was initiated for the participants. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Charlson Comorbidity Index (CCI) | CCI included myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, moderate/severe liver disease, diabetes with and without chronic complication, hemiplegia or paraplegia, renal disease, any malignancy (including leukemia and lymphoma), metastatic solid tumor, and AIDS/HIV. CCI score range from 0 to 33, where "0" = low comorbid condition and "33" = high comorbid condition, higher scores indicated more comorbidity and higher mortality risk. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Mean | Standard Deviation | Units on a scale |
|
| HAS-BLED Score | In this baseline measure, HAS-BLED score was assessed by combining score of 8 risk factors (hypertension, abnormal kidney function, abnormal liver function, age > 65 years, stroke, bleeding history, labile international normalized ratio [INR], and drugs [antiplatelet agents and Non-steroidal anti-inflammatory drugs {NSAIDs}] or alcohol use). Score ranged from 0-9, where "0" indicates low risk and "9" indicates high risk, where higher scores indicated more bleeding risk. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Mean | Standard Deviation | Units on a scale |
|
| Number of Participants With Previous use of Medications | In this baseline measure, previous use of medications such as corticosteroids, non-steroidal anti-inflammatory drug (NSAIDs), angiotensin-converting-enzyme inhibitors (ACE) inhibitors, angiotensin II receptor blockers, anti-platelets, beta-blockers, calcium-channel blockers, selective serotonin reuptake inhibitors (SSRI), proton pump inhibitors, diuretics, thiazides, vasodilators, estrogens, cyclooxygenase-2 inhibitors, and triazole antifungal agents were reported. A participant could have used more than 1 medication. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| Number of Participants With Comorbidities | In this baseline measure, number of participants with various comorbidities such as antiphospholipid syndrome, asthma, history of cancer, chronic obstructive pulmonary disease (COPD), chronic kidney disease, chronic liver disease, diabetes mellitus, fracture, heart failure, hyperlipidemia, hypertension, ischemic heart disease, myocardial infarction, stroke, and trauma were reported. A participant can have more than 1 comorbidity. | Baseline characteristic is reported in separate rows for participants with active cancer and without active cancer. | Count of Participants | Participants |
|
| OG000 | Warfarin-Based Therapy | Participants diagnosed with VTE, initiated warfarin-based therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG001 | NOAC-Based Therapy | Participants diagnosed with VTE, initiated NOAC-based (apixaban, dabigatran, edoxaban, or rivaroxaban) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG002 | NOAC-Based Therapy: Apixaban | Participants diagnosed with VTE, initiated apixaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG003 | NOAC-Based Therapy: Dabigatran | Participants diagnosed with VTE, initiated dabigatran (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG004 | NOAC-Based Therapy: Edoxaban | Participants diagnosed with VTE, initiated edoxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG005 | NOAC-Based Therapy: Rivaroxaban | Participants diagnosed with VTE, initiated rivaroxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
| OG006 | PAC Only | Participants diagnosed with VTE, initiated PAC only therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. |
|
|
| Primary | Time to Treatment Interruption | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with interruption event;"Number Analyzed": participants evaluable for specified rows. | Posted | Median | Inter-Quartile Range | Days | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
|
|
|
| Primary | Number of Participants Who Switched to Another Anticoagulant Therapy | Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
|
|
|
| Primary | Time to Treatment Switch | Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event; "Number Analyzed": participants evaluable for specified rows. | Posted | Median | Inter-Quartile Range | Days | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants Who Completely Discontinued Index Anticoagulant Treatment | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Time to Treatment Discontinuation | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC,hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed":participants evaluable for this outcome measure with discontinuation event;"Number Analyzed":participants evaluable for specified rows. | Posted | Median | Inter-Quartile Range | Days | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Overall Index Anticoagulant Treatment Duration | Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Median | Inter-Quartile Range | Days | From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Count of Participants | Participants | Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with interruption event;"Number Analyzed": participants evaluable for specified rows. | Posted | Count of Participants | Participants | Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major bleeding" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "complications of VTE" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "thromboembolism" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major surgery" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "cancer-related event" are reported among participants without active cancer. Data not collected and reported for participants with active because all participants already had cancer. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "kidney function change" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "liver function change" are reported. | All eligible participants. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event. "Number Analyzed (n)": participants evaluable for specified rows. n =0 as switch in the same treatment arm not feasible. | Posted | Count of Participants | Participants | Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| Primary | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC,hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed":participants evaluable for this outcome measure with discontinuation event;"Number Analyzed":participants evaluable for specified rows. | Posted | Count of Participants | Participants | Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | NOAC-Based Therapy: Apixaban | Participants diagnosed with VTE, initiated apixaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | NOAC-Based Therapy: Dabigatran | Participants diagnosed with VTE, initiated dabigatran (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | NOAC-Based Therapy: Edoxaban | Participants diagnosed with VTE, initiated edoxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | NOAC-Based Therapy: Rivaroxaban | Participants diagnosed with VTE, initiated rivaroxaban (NOAC-based) therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | PAC Only | Participants diagnosed with VTE, initiated PAC only therapy in real world practice within 30 days of their VTE diagnosis between 1 March 2012 and 30 June 2019, were included in this cohort. | 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.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| 40-65 years |
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| >=65 years |
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| Male |
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| PE with/without DVT |
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| Medical aid |
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| Veterans |
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| 2013 |
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| 2014 |
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| 2015 |
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| 2016 |
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| 2017 |
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| 2018 |
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| 2019 |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| With Active Cancer |
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| Complications of VTE: Without Active Cancer |
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| Thromboembolism: Without Active Cancer |
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| Major Surgery: Without Active Cancer |
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| Cancer-related Event: Without Active Cancer |
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| Kidney Function Changes: Without Active Cancer |
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| Liver Function Change: Without Active Cancer |
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| Major Bleeding: With Active Cancer |
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| Complications of VTE: With Active Cancer |
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| Thromboembolism: With Active Cancer |
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| Major Surgery: With Active Cancer |
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| Cancer-related Event: With Active Cancer |
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| Kidney Function Changes: With Active Cancer |
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| Liver Function Change: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Switched to NOAC: Without Active Cancer |
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| Switched to PAC: Without Active Cancer |
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| Switched to Apixaban: Without Active Cancer |
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| Switched to Dabigatran: Without Active Cancer |
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| Switched to Edoxaban: Without Active Cancer |
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| Switched to Rivaroxaban: Without Active Cancer |
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| Switched to Warfarin: With Active Cancer |
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| Switched to NOAC: With Active Cancer |
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| Switched to PAC: With Active Cancer |
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| Switched to Apixaban: With Active Cancer |
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| Switched to Dabigatran: With Active Cancer |
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| Switched to Edoxaban: With Active Cancer |
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| Switched to Rivaroxaban: With Active Cancer |
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| Complications of VTE: Without Active Cancer |
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| Thromboembolism: Without Active Cancer |
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| Major Surgery: Without Active Cancer |
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| Cancer-related Event: Without Active Cancer |
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| Kidney Function Changes: Without Active Cancer |
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| Liver Function Change: Without Active Cancer |
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| Major Bleeding: With Active Cancer |
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| Complications of VTE: With Active Cancer |
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| Thromboembolism: With Active Cancer |
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| Major Surgery: With Active Cancer |
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| Cancer-related Event: With Active Cancer |
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| Kidney Function Changes: With Active Cancer |
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| Liver Function Change: With Active Cancer |
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