Trial Outcomes & Findings for A Study to Compare Health Care Costs Between Apixaban and Low Molecular Weight Heparin in Patients With Venous Thromboembolism and Cancer (NCT NCT05643885)

NCT ID: NCT05643885

Last Updated: 2025-10-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 7304 participants
• Primary outcome timeframe: 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
• Results posted on: 2025-10-17

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	4299	3005
Overall Study COMPLETED	4299	3005
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Apixaban n=4299 Participants 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.	LMWH n=3005 Participants 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.	Total n=7304 Participants Total of all reporting groups
Age, Customized 18-24 years	29 Participants n=4299 Participants	54 Participants n=3005 Participants	83 Participants n=7304 Participants
Age, Customized 25-34 years	75 Participants n=4299 Participants	79 Participants n=3005 Participants	154 Participants n=7304 Participants
Age, Customized 35-44 years	234 Participants n=4299 Participants	239 Participants n=3005 Participants	473 Participants n=7304 Participants
Age, Customized 45-54 years	802 Participants n=4299 Participants	621 Participants n=3005 Participants	1423 Participants n=7304 Participants
Age, Customized 55-64 years	1951 Participants n=4299 Participants	1406 Participants n=3005 Participants	3357 Participants n=7304 Participants
Age, Customized 65-74 years	799 Participants n=4299 Participants	458 Participants n=3005 Participants	1257 Participants n=7304 Participants
Age, Customized >= 75 years	409 Participants n=4299 Participants	148 Participants n=3005 Participants	557 Participants n=7304 Participants
Sex: Female, Male Female	2119 Participants n=4299 Participants	1558 Participants n=3005 Participants	3677 Participants n=7304 Participants
Sex: Female, Male Male	2180 Participants n=4299 Participants	1447 Participants n=3005 Participants	3627 Participants n=7304 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4288 Participants 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.	LMWH n=3022 Participants 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.
Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events	16420 USD per participant per month Standard Deviation 23354	21312 USD per participant per month Standard Deviation 27337

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4288 Participants 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.	LMWH n=3022 Participants 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.
Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events	2452 USD per participant per month Standard Deviation 5376	2654 USD per participant per month Standard Deviation 4701

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4288 Participants 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.	LMWH n=3022 Participants 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.
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events	8028 USD per participant per month Standard Deviation 11644	10042 USD per participant per month Standard Deviation 12759

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4288 Participants 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.	LMWH n=3022 Participants 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.
Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events	5940 USD per participant per month Standard Deviation 17512	8616 USD per participant per month Standard Deviation 22667

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=371 Participants 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.	LMWH n=391 Participants 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.
Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events	11277 USD per participant per month Standard Deviation 19873	13074 USD per participant per month Standard Deviation 21342

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=371 Participants 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.	LMWH n=391 Participants 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.
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events	827 USD per participant per month Standard Deviation 2367	884 USD per participant per month Standard Deviation 2430

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=371 Participants 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.	LMWH n=391 Participants 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.
Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events	10450 USD per participant per month Standard Deviation 19670	12190 USD per participant per month Standard Deviation 21175

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=205 Participants 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.	LMWH n=225 Participants 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.
Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events	19384 USD per participant per month Standard Deviation 30260	22719 USD per participant per month Standard Deviation 30865

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=205 Participants 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.	LMWH n=225 Participants 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.
Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events	268 USD per participant per month Standard Deviation 1021	346 USD per participant per month Standard Deviation 1256

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=205 Participants 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.	LMWH n=225 Participants 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.
Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events	19116 USD per participant per month Standard Deviation 30241	22373 USD per participant per month Standard Deviation 30822

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=907 Participants 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.	LMWH n=777 Participants 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.
Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events	4883 USD per participant per month Standard Deviation 13142	5227 USD per participant per month Standard Deviation 14230

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=907 Participants 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.	LMWH n=777 Participants 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.
Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events	431 USD per participant per month Standard Deviation 1134	483 USD per participant per month Standard Deviation 1291

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=907 Participants 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.	LMWH n=777 Participants 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.
Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events	4452 USD per participant per month Standard Deviation 13126	4744 USD per participant per month Standard Deviation 14232

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=1837 Participants 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.	LMWH n=1663 Participants 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.
Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events	0.4 Hospitalizations PPPM Standard Deviation 0.4	0.4 Hospitalizations PPPM Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4288 Participants 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.	LMWH n=3022 Participants 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.
Mean Number of Outpatient Medical Visits PPPM for VTE Events Physician office visits	3.0 Outpatient medical visits PPPM Standard Deviation 3.0	3.5 Outpatient medical visits PPPM Standard Deviation 3.1
Mean Number of Outpatient Medical Visits PPPM for VTE Events ER only visits	0.2 Outpatient medical visits PPPM Standard Deviation 0.3	0.2 Outpatient medical visits PPPM Standard Deviation 0.4
Mean Number of Outpatient Medical Visits PPPM for VTE Events laboratory or pathology visits	5.6 Outpatient medical visits PPPM Standard Deviation 7.0	8.1 Outpatient medical visits PPPM Standard Deviation 9.5
Mean Number of Outpatient Medical Visits PPPM for VTE Events Radiology	1.6 Outpatient medical visits PPPM Standard Deviation 2.8	2.1 Outpatient medical visits PPPM Standard Deviation 3.1
Mean Number of Outpatient Medical Visits PPPM for VTE Events Surgical services	0.4 Outpatient medical visits PPPM Standard Deviation 0.7	0.6 Outpatient medical visits PPPM Standard Deviation 0.8
Mean Number of Outpatient Medical Visits PPPM for VTE Events Ancillary/other services	6.5 Outpatient medical visits PPPM Standard Deviation 7.0	7.7 Outpatient medical visits PPPM Standard Deviation 7.1

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=4287 Participants 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.	LMWH n=3021 Participants 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.
Mean Number of Prescription Fills PPPM for VTE Events	5.0 Prescription fills PPPM Standard Deviation 4.1	5.6 Prescription fills PPPM Standard Deviation 4.5

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=371 Participants 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.	LMWH n=391 Participants 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.
Mean Number of Hospitalizations PPPM for Recurrent VTE Events	0.6 Hospitalizations PPPM Standard Deviation 0.5	0.6 Hospitalizations PPPM Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=371 Participants 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.	LMWH n=391 Participants 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.
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events Physician office visits	0.7 Outpatient medical visits PPPM Standard Deviation 1.7	0.6 Outpatient medical visits PPPM Standard Deviation 1.6
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events ER only visits	0.0 Outpatient medical visits PPPM Standard Deviation 0.1	0.0 Outpatient medical visits PPPM Standard Deviation 0.1
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events Laboratory or pathology visits	0.6 Outpatient medical visits PPPM Standard Deviation 1.8	0.8 Outpatient medical visits PPPM Standard Deviation 2.9
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events Radiology	0.2 Outpatient medical visits PPPM Standard Deviation 0.6	0.2 Outpatient medical visits PPPM Standard Deviation 0.8
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events Surgical services	0.0 Outpatient medical visits PPPM Standard Deviation 0.1	0.0 Outpatient medical visits PPPM Standard Deviation 0.1
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events Ancillary or other services	1.1 Outpatient medical visits PPPM Standard Deviation 3.5	0.7 Outpatient medical visits PPPM Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=205 Participants 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.	LMWH n=225 Participants 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.
Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events	0.6 Hospitalizations PPPM Standard Deviation 0.5	0.6 Hospitalizations PPPM Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=205 Participants 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.	LMWH n=225 Participants 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.
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events Physician office visits	0.3 Outpatient medical visits PPPM Standard Deviation 0.9	0.5 Outpatient medical visits PPPM Standard Deviation 1.4
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events ER only visits	0.0 Outpatient medical visits PPPM Standard Deviation 0.1	0.0 Outpatient medical visits PPPM Standard Deviation 0.2
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events Laboratory or pathology visits	0.4 Outpatient medical visits PPPM Standard Deviation 1.6	0.3 Outpatient medical visits PPPM Standard Deviation 1.2
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events Radiology	0.1 Outpatient medical visits PPPM Standard Deviation 0.3	0.0 Outpatient medical visits PPPM Standard Deviation 0.2
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events Surgical services	0.0 Outpatient medical visits PPPM Standard Deviation 0.2	0.1 Outpatient medical visits PPPM Standard Deviation 0.4
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events Ancillary or other services	0.2 Outpatient medical visits PPPM Standard Deviation 0.9	0.3 Outpatient medical visits PPPM Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=907 Participants 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.	LMWH n=777 Participants 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.
Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events	0.5 Hospitalizations PPPM Standard Deviation 0.4	0.5 Hospitalizations PPPM Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Apixaban n=907 Participants 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.	LMWH n=777 Participants 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.
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events Physician office visits	0.3 Outpatient medical visits PPPM Standard Deviation 0.7	0.4 Outpatient medical visits PPPM Standard Deviation 0.8
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events ER only visits	0.1 Outpatient medical visits PPPM Standard Deviation 0.2	0.1 Outpatient medical visits PPPM Standard Deviation 0.2
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events Radiology	0.1 Outpatient medical visits PPPM Standard Deviation 0.5	0.1 Outpatient medical visits PPPM Standard Deviation 0.3
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events Surgical services	0.1 Outpatient medical visits PPPM Standard Deviation 0.2	0.1 Outpatient medical visits PPPM Standard Deviation 0.2
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events Ancillary or other services	0.3 Outpatient medical visits PPPM Standard Deviation 1.0	0.4 Outpatient medical visits PPPM Standard Deviation 1.4
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events Laboratory or pathology visits	0.7 Outpatient medical visits PPPM Standard Deviation 1.9	0.9 Outpatient medical visits PPPM Standard Deviation 2.8

Adverse Events

Apixaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LMWH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER