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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05643885 | Registry Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate the health care resource utilization and costs associated with treating patients diagnosed with cancer and venous thromboembolism with apixaban or low molecular weight heparin. This is a retrospective database analysis of health care claims data. All-cause costs as well as costs associated with recurrent VTE, major bleeding, and clinically relevant nonmajor bleeding will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apixaban | patients treated with apixaban | ||
| Low molecular weight heparin (LMWH) | patients treated with low molecular weight heparin |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events | The all-cause healthcare cost for VTE event was defined as the sum of total cost associated with the total inpatient, total outpatient, and total pharmacy costs for the VTE event. Costs were converted to 2021 United States dollars (USD) using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events | The all-cause healthcare outpatient pharmacy cost for VTE event was defined as the total cost associated with the outpatient pharmacy costs for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events | The all-cause healthcare outpatient medical cost for VTE event was defined as the total cost associated with the outpatient medical costs (excluding pharmacy costs) for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events | Mean number of hospitalizations PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with active cancer who are newly diagnosed with venous thromboembolism (VTE) and treated with apixaban or low molecular weight heparin within 30 days following the VTE.
Patients will be identified from the PharMetrics Plus health care claims database between the period of January 2017 and October 2021 if they have a VTE diagnosis and claim for apixaban or low molecular weight heparin during this time.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational | 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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The date of the first apixaban or LMWH prescription was considered as the index date. The analysis was conducted using retrospective data from 01 January 2016 through 31 December 2021. Available data was extracted and evaluated during 24 months of this retrospective observational study.
Participants with newly diagnosed venous thromboembolism (VTE) with active cancer who initiated apixaban or low molecular weight heparin (LMWH) within 30 days following VTE diagnosis were included in this study and data for eligible participants was retrospectively analyzed using IQVIA's database PharMetrics Plus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Participants with newly diagnosed VTE with active cancer who received apixaban within 30 days following the VTE diagnosis and no other anticoagulant (LMWH, other oral anti-coagulant [OAC], heparin or fondaparinux) between index VTE encounter date (first date of claim with a VTE diagnosis code) and the index date. |
| FG001 | LMWH | Participants with newly diagnosed VTE with active cancer who received LMWH within 30 days following the VTE diagnosis with a duration of at least 14 days and no apixaban or other anticoagulants between index VTE encounter and index date + 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Participants with newly diagnosed VTE with active cancer who received apixaban within 30 days following the VTE diagnosis and no other anticoagulant (LMWH, other OAC, heparin or fondaparinux) between index VTE encounter date (first date of claim with a VTE diagnosis code) and the index date. |
| BG001 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events | The all-cause healthcare cost for VTE event was defined as the sum of total cost associated with the total inpatient, total outpatient, and total pharmacy costs for the VTE event. Costs were converted to 2021 United States dollars (USD) using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized inverse probability of treatment weighting (IPTW). Hence, numbers are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
Not applicable as adverse events and all-cause mortality were not planned to be assessed or monitored during this study
This observational retrospective study involved data that existed as structured data by the time of study start. In these data sources, individual participants data were not retrieved or validated. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable participants, identifiable reporter, a suspect product, and event) was not met. Hence, adverse events were not assessed or evaluated which explains "0" participants at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban | Participants with newly diagnosed VTE with active cancer who received apixaban within 30 days following the VTE diagnosis and no other anticoagulant (LMWH, other OAC, heparin or fondaparinux) between index VTE encounter date (first date of claim with a VTE diagnosis code) and the index date. |
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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 | Jul 29, 2022 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events | The all-cause healthcare hospitalization cost for VTE event was defined as the cost associated with the inpatient hospitalization for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (international classification of diseases, tenth revision, clinical modification [ICD-10-CM] diagnosis codes). Recurrent VTE all cause healthcare costs were defined as the costs associated with the first recurrent VTE hospitalization and all subsequent VTE costs in the inpatient (primary or secondary diagnosis) or outpatient (any position) setting. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Recurrent VTE outpatient medical costs included costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). The all-cause healthcare hospitalization cost for recurrent VTE event was defined as the cost associated with the inpatient hospitalization for the recurrent VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis) or outpatient setting (any position). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Major bleeding-related all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH, and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events | CRNM bleeding-related all cause healthcare costs were combination of bleeding related inpatient and outpatient costs. CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. CRNM bleeding all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room (ER) visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Outpatient Medical Visits PPPM for VTE Events | Mean number of outpatient medical visits PPPM for VTE events are reported in this outcome measure. Outpatient visits included physician office visits, ER visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Prescription Fills PPPM for VTE Events | Mean number of prescription fills PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Hospitalizations PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
| LMWH |
Participants with newly diagnosed VTE with active cancer who received LMWH within 30 days following the VTE diagnosis with a duration of at least 14 days and no apixaban or other anticoagulants between index VTE encounter and index date + 14 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| ID |
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| Title |
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| Description |
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| OG000 | Apixaban | Participants with newly diagnosed VTE with active cancer who received apixaban within 30 days following the VTE diagnosis and no other anticoagulant (LMWH, other OAC, heparin or fondaparinux) between index VTE encounter date (first date of claim with a VTE diagnosis code) and the index date. |
| OG001 | LMWH | Participants with newly diagnosed VTE with active cancer who received LMWH within 30 days following the VTE diagnosis with a duration of at least 14 days and no apixaban or other anticoagulants between index VTE encounter and index date + 14 days. |
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| Primary | Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events | The all-cause healthcare outpatient pharmacy cost for VTE event was defined as the total cost associated with the outpatient pharmacy costs for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events | The all-cause healthcare outpatient medical cost for VTE event was defined as the total cost associated with the outpatient medical costs (excluding pharmacy costs) for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events | The all-cause healthcare hospitalization cost for VTE event was defined as the cost associated with the inpatient hospitalization for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (international classification of diseases, tenth revision, clinical modification [ICD-10-CM] diagnosis codes). Recurrent VTE all cause healthcare costs were defined as the costs associated with the first recurrent VTE hospitalization and all subsequent VTE costs in the inpatient (primary or secondary diagnosis) or outpatient (any position) setting. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Recurrent VTE outpatient medical costs included costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). The all-cause healthcare hospitalization cost for recurrent VTE event was defined as the cost associated with the inpatient hospitalization for the recurrent VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis) or outpatient setting (any position). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Major bleeding-related all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH, and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events | CRNM bleeding-related all cause healthcare costs were combination of bleeding related inpatient and outpatient costs. CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. CRNM bleeding all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room (ER) visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Primary | Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | USD per participant per month | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events | Mean number of hospitalizations PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Outpatient Medical Visits PPPM for VTE Events | Mean number of outpatient medical visits PPPM for VTE events are reported in this outcome measure. Outpatient visits included physician office visits, ER visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed (N)" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section. All participants reported under "N" contributed data to table; however, may not have evaluable data for every row. Number analyzed (n)= number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Outpatient medical visits PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Prescription Fills PPPM for VTE Events | Mean number of prescription fills PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Prescription fills PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Hospitalizations PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events | Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed (N)" reflects the pseudo-population created using stabilized IPTW. All participants reported under "N" contributed data to table; however, may not have evaluable data for every row. Number analyzed (n)= number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Outpatient medical visits PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events | Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed (N)" reflects the pseudo-population created using stabilized IPTW. All participants reported under "N" contributed data to table; however, may not have evaluable data for every row. Number analyzed (n)= number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Outpatient medical visits PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW and who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| Secondary | Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events | CRNM bleeding was defined as an inpatient encounter 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 GI bleeding or other non-critical types of bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis. | Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed (N)" reflects the pseudo-population created using stabilized IPTW. All participants reported under "N" contributed data to table; however, may not have evaluable data for every row. Number analyzed (n)= number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Outpatient medical visits PPPM | From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | LMWH | Participants with newly diagnosed VTE with active cancer who received LMWH within 30 days following the VTE diagnosis with a duration of at least 14 days and no apixaban or other anticoagulants between index VTE encounter and index date + 14 days. | 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.
| ER only visits |
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| laboratory or pathology visits |
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| Radiology |
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| Surgical services |
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| Ancillary/other services |
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| <0.0001 |
| Superiority |
| laboratory or pathology visits | Weighted t-test | <0.0001 | Superiority |
| Radiology | Weighted t-test | <0.0001 | Superiority |
| Surgical services | Weighted t-test | <0.0001 | Superiority |
| Ancillary/other services | Weighted t-test | <0.0001 | Superiority |
| ER only visits |
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| Laboratory or pathology visits |
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| Radiology |
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| Surgical services |
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| Ancillary or other services |
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| =0.2747 |
| Superiority |
| Laboratory or pathology visits | Weighted t-test | =0.1049 | Superiority |
| Radiology | Weighted t-test | =0.8425 | Superiority |
| Surgical services | Weighted t-test | =0.9755 | Superiority |
| Ancillary or other services | Weighted t-test | =0.0582 | Superiority |
| ER only visits |
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|
| Laboratory or pathology visits |
|
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| Radiology |
|
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| Surgical services |
|
|
| Ancillary or other services |
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| =0.9034 |
| Superiority |
| Laboratory or pathology visits | Weighted t-test | =0.5452 | Superiority |
| Radiology | Weighted t-test | =0.1644 | Superiority |
| Surgical services | Weighted t-test | =0.0650 | Superiority |
| Ancillary or other services | Weighted t-test | =0.3866 | Superiority |
| ER only visits |
|
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| Laboratory or pathology visits |
|
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| Radiology |
|
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| Surgical services |
|
|
| Ancillary or other services |
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| =0.8634 |
| Superiority |
| Laboratory or pathology visits | Weighted t-test | =0.0399 | Superiority |
| Radiology | Weighted t-test | =0.0996 | Superiority |
| Surgical services | Weighted t-test | =0.7655 | Superiority |
| Ancillary or other services | Weighted t-test | =0.1499 | Superiority |