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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
The purpose of this study is to assess outpatient treatment patterns following hospitalization for venous thromboembolism (VTE). VTE is a condition that occurs when blood clot forms in the vein.
This is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. The study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. Assessment includes treatment persistence, switch, and stopping therapy, along with recurrent VTE and bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apixaban | Patients treated with apixaban |
| |
| warfarin | patients treated with warfarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apixaban | Drug | patients treated with apixaban |
| |
| warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital | Following discharge from inpatient hospitalization, participants who continued apixaban or warfarin, respectively, in the outpatient setting (with outpatient treatment claim occurring on or within 30-days following the hospital discharge date) were identified. | From hospital discharge date through 30 days following discharge date (from the data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Mean Number of Persistent Days | Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim. | From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date | Discontinuation was defined as greater than or equal to (>=) 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. | At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date | Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Recurrent VTE Events | Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Incidence rate was defined as the number of events (recurrent VTE) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are hospitalized for venous thromboembolism (VTE) and treated with apixaban or warfarin during the hospitalization. Patients will be identified through linkage of IQVIA's hospital charge data master database (CDM) with outpatient professional fee medical claims (Dx) and longitudinal prescription claims (LRx) databases during the period of July 2018 and August 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10017 | United States |
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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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It is a retrospective population-based register study. Available data from eligible participants was evaluated in approximately 7 months of this retrospective, observational study per its objectives.
Data of eligible participants, who had hospitalization for primary diagnosis of venous thromboembolism (VTE) and received apixaban or warfarin, was extracted from databases and health claim records from 01 July 2017 to 31 December 2022 (study data identification duration of 5.5 years).
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Participants who received apixaban (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. |
| FG001 | Warfarin | Participants who received warfarin (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Participants who received apixaban (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational 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, Categorical | Count of Participants |
| 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 Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital | Following discharge from inpatient hospitalization, participants who continued apixaban or warfarin, respectively, in the outpatient setting (with outpatient treatment claim occurring on or within 30-days following the hospital discharge date) were identified. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Count of Participants | Participants | From hospital discharge date through 30 days following discharge date (from the data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
Not applicable as adverse events were not collected for the study
Due to non-interventional nature of the study and nature of data sources, the minimum criteria for reporting an adverse event (that is, identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence adverse events were not planned to be collected and reported.
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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 who received apixaban (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. |
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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 | Feb 14, 2023 | Sep 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Drug |
patients treated with warfarin |
|
| At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date | Participants were considered to have switched if they filled a prescription for oral anticoagulant (OAC) other than apixaban or warfarin, respectively (identified through national drug codes [NDC] codes in longitudinal prescription claims [LRx]) or for parenteral anticoagulant (PAC) within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date | Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Median Time to Discontinuation From the Index Treatment | Time from treatment index date to discontinuation date was described in this outcome measure. Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. | From initiation of index treatment post-discharge till its discontinuation (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Median Time to Switch From the Index Treatment | Time from treatment index date to treatment switch date was described in this outcome measure. Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | From initiation of index treatment post-discharge till switch (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Median Time to Recurrent VTE | Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Treatment index date: date of first outpatient apixaban or warfarin claim. | From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Incidence Rate of Major Bleeding Events | Major bleeding was defined as inpatient hospitalization with primary diagnosis of gastro-intestinal bleeding, intracranial hemorrhage (ICH) or other major bleeding. Incidence rate was defined as the number of events (major bleeding) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim. | From first hospitalization discharge through first major bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
| Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events | CRNM bleeding was defined as inpatient hospitalization with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM gastrointestinal (GI) bleeding or other non-critical types of bleeding. Incidence rate was defined as the number of events (CRNM bleeding) per 100 participant years. | From first hospitalization discharge through first CRNM bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
Participants who received warfarin (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| OG001 | Warfarin | Participants who received warfarin (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. |
|
|
| Primary | Mean Number of Persistent Days | Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Mean | Standard Deviation | Days | From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date | Discontinuation was defined as greater than or equal to (>=) 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | Percentage of Participants | At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date | Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | Percentage of Participants | At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date | Participants were considered to have switched if they filled a prescription for oral anticoagulant (OAC) other than apixaban or warfarin, respectively (identified through national drug codes [NDC] codes in longitudinal prescription claims [LRx]) or for parenteral anticoagulant (PAC) within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | Percentage of Participants | At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date | Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | Percentage of Participants | At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Median Time to Discontinuation From the Index Treatment | Time from treatment index date to discontinuation date was described in this outcome measure. Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Median | Inter-Quartile Range | Months | From initiation of index treatment post-discharge till its discontinuation (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Primary | Median Time to Switch From the Index Treatment | Time from treatment index date to treatment switch date was described in this outcome measure. Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Median | 95% Confidence Interval | Months | From initiation of index treatment post-discharge till switch (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Secondary | Incidence Rate of Recurrent VTE Events | Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Incidence rate was defined as the number of events (recurrent VTE) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | Events per 100 participant-years | From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Secondary | Median Time to Recurrent VTE | Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Median | Full Range | Months | From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Secondary | Incidence Rate of Major Bleeding Events | Major bleeding was defined as inpatient hospitalization with primary diagnosis of gastro-intestinal bleeding, intracranial hemorrhage (ICH) or other major bleeding. Incidence rate was defined as the number of events (major bleeding) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | From first hospitalization discharge through first major bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| Secondary | Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events | CRNM bleeding was defined as inpatient hospitalization with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM gastrointestinal (GI) bleeding or other non-critical types of bleeding. Incidence rate was defined as the number of events (CRNM bleeding) per 100 participant years. | Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | From first hospitalization discharge through first CRNM bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Warfarin | Participants who received warfarin (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study. | 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.
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |