<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03026556</url>
  </required_header>
  <id_info>
    <org_study_id>1160-0274</org_study_id>
    <nct_id>NCT03026556</nct_id>
  </id_info>
  <brief_title>The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis</brief_title>
  <official_title>Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban &amp; Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health ResearchTx, LLC (HRTX)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>inVentiv Health Clinical (iVH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Department of Defense (DOD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of newly initiated&#xD;
      dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in&#xD;
      comparison to newly initiated rivaroxaban users and newly initiated apixaban users&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">August 23, 2017</completion_date>
  <primary_completion_date type="Actual">August 23, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke Overall (Hemorrhagic, Ischemic, Uncertain)</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:&#xD;
The day of discontinuation of the index NOAC exposure;&#xD;
The day before a switch to an anticoagulant different from the index exposure;&#xD;
The day before a change in dose for the index NOAC;&#xD;
The end of continuous eligibility of a patient in the health plan (disenrollment);&#xD;
The end of the study observation period; or&#xD;
The date of death of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Major Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ischemic Stroke</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of ischemic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorrhagic Stroke</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Intracranial Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of major intracranial bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Extracranial Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major GI Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Urogenital Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of major urogenital bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Other Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of major other bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper GI Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower GI Bleeding</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIA</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
    <description>The event rate of all-cause mortality in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42534</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Dabigatran vs. Rivaroxaban</arm_group_label>
    <description>OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dabigatran vs. Apixaban</arm_group_label>
    <description>OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran vs. Rivaroxaban</intervention_name>
    <description>observed for 6 years</description>
    <arm_group_label>Dabigatran vs. Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran vs. Apixaban</intervention_name>
    <description>Observed for 6 years</description>
    <arm_group_label>Dabigatran vs. Apixaban</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        NVAF patients, ≥18 years of age, enrolled within the DoD Military Health System, who have&#xD;
        newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from&#xD;
        OAC use prior to first (index) NOAC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18+ on index date&#xD;
&#xD;
          -  Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban&#xD;
             identified by pharmacy claim during the study period. The first dispensing date of&#xD;
             either study drug will be defined as the index date;&#xD;
&#xD;
          -  Patients must be treatment naïve from all OAC use prior to the first NOAC&#xD;
             prescription, during study period.&#xD;
&#xD;
          -  Patients must have at least 12 months of continuous eligibility prior to the index&#xD;
             date;&#xD;
&#xD;
          -  Patients must have at least one diagnosis code of atrial fibrillation, defined as&#xD;
             International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM&#xD;
             diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index&#xD;
             period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC&#xD;
        drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the&#xD;
        pre-index period&#xD;
&#xD;
        Having at least one claim for alternative indications; orthopedic procedures, Venous&#xD;
        thromboembolism (VTE) (includes deep vein thrombosis (DVT ) &amp; PE)) and the index NOAC&#xD;
        prescription at the same time, or, the alternative indication for anticoagulant occurring&#xD;
        within 3 months prior to index date in pre-period Having at least one claim with any of the&#xD;
        following diagnoses or procedure codes in order to exclude patients with &quot;transient&quot; causes&#xD;
        of Afib (3 months prior to index date in pre-period):&#xD;
&#xD;
          -  Cardiac surgery&#xD;
&#xD;
          -  Pericarditis&#xD;
&#xD;
          -  Myocarditis Having at least one medical claim with any of the following diagnoses or&#xD;
             procedures codes in order to exclude patients with &quot;valvular&quot; Afib (pre-period):&#xD;
&#xD;
          -  Mitral stenosis&#xD;
&#xD;
          -  Mitral stenosis with insufficiency&#xD;
&#xD;
          -  Mitral valve stenosis and aortic valve stenosis&#xD;
&#xD;
          -  Mitral valve stenosis and aortic valve insufficiency&#xD;
&#xD;
          -  Diseases of other endocardial structures&#xD;
&#xD;
          -  Other and unspecified rheumatic heart diseases&#xD;
&#xD;
          -  Open heart valvuloplasty without replacement&#xD;
&#xD;
          -  Open and other replacement of unspecified heart valve&#xD;
&#xD;
          -  Open and other replacement of aortic valve&#xD;
&#xD;
          -  Open and other replacement of mitral valve&#xD;
&#xD;
          -  Open and other replacement of pulmonary valve&#xD;
&#xD;
          -  Open and other replacement of tricuspid valve&#xD;
&#xD;
          -  Heart valve replaced by transplant&#xD;
&#xD;
          -  Heart valve replaced by a mechanical device/prosthesis&#xD;
&#xD;
          -  Atrioventricular valve repair&#xD;
&#xD;
          -  Aortic valve valvuloplasty&#xD;
&#xD;
          -  Unlisted procedure, cardiac surgery&#xD;
&#xD;
          -  Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic&#xD;
             approach&#xD;
&#xD;
          -  Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for&#xD;
             catheter-delivered aortic valve replacement; without cardiopulmonary bypass&#xD;
&#xD;
          -  Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for&#xD;
             catheter-delivered aortic valve replacement; with cardiopulmonary bypass&#xD;
&#xD;
          -  Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other&#xD;
             than homograft or stentless valve&#xD;
&#xD;
          -  Valvuloplasty, mitral valve, with cardiopulmonary bypass&#xD;
&#xD;
          -  Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring&#xD;
&#xD;
          -  Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with&#xD;
             or without ring&#xD;
&#xD;
          -  Replacement, mitral valve, with cardiopulmonary bypass&#xD;
&#xD;
          -  Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach&#xD;
&#xD;
          -  Replacement, pulmonary valve&#xD;
&#xD;
          -  Valvectomy, tricuspid valve, with cardiopulmonary bypass&#xD;
&#xD;
          -  Valvuloplasty, tricuspid valve; without ring insertion&#xD;
&#xD;
          -  Valvuloplasty, tricuspid valve; with ring insertion&#xD;
&#xD;
          -  Replacement, tricuspid valve, with cardiopulmonary bypass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inventiv Health</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>August 20, 2018</results_first_submitted>
  <results_first_submitted_qc>February 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03026556/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This is a Non-interventional retrospective cohort study based on existing data with propensity score matching (PSM) in Non-valvular Atrial Fibrillation (NVAF) patients with new Non-Vitamin K antagonist oral anticoagulant (NOAC) use.</recruitment_details>
      <pre_assignment_details>The study was a US retrospective database of the Department of Defense (DoD) beneficiary population. Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran</title>
          <description>Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran .</description>
        </group>
        <group group_id="P2">
          <title>Rivaroxaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .</description>
        </group>
        <group group_id="P3">
          <title>Apixaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12763"/>
                <participants group_id="P2" count="17177"/>
                <participants group_id="P3" count="12594"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12763"/>
                <participants group_id="P2" count="17177"/>
                <participants group_id="P3" count="12594"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran</title>
          <description>Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran .</description>
        </group>
        <group group_id="B2">
          <title>Rivaroxaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .</description>
        </group>
        <group group_id="B3">
          <title>Apixaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12763"/>
            <count group_id="B2" value="17177"/>
            <count group_id="B3" value="12594"/>
            <count group_id="B4" value="42534"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="17177"/>
                    <count group_id="B3" value="12594"/>
                    <count group_id="B4" value="42534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.89" spread="10.03"/>
                    <measurement group_id="B2" value="71.28" spread="9.70"/>
                    <measurement group_id="B3" value="72.35" spread="8.93"/>
                    <measurement group_id="B4" value="71.48" spread="9.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Rivaroxaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="12763"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="25526"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.89" spread="10.03"/>
                    <measurement group_id="B2" value="70.92" spread="10.07"/>
                    <measurement group_id="B4" value="70.91" spread="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Apixaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4802"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4802"/>
                    <count group_id="B4" value="9604"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.15" spread="10.23"/>
                    <measurement group_id="B3" value="70.20" spread="10.02"/>
                    <measurement group_id="B4" value="70.18" spread="10.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="17177"/>
                    <count group_id="B3" value="12594"/>
                    <count group_id="B4" value="42534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7902"/>
                    <measurement group_id="B2" value="10389"/>
                    <measurement group_id="B3" value="7499"/>
                    <measurement group_id="B4" value="25790"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4861"/>
                    <measurement group_id="B2" value="6788"/>
                    <measurement group_id="B3" value="5095"/>
                    <measurement group_id="B4" value="16744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Rivaroxaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="12763"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="25526"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7902"/>
                    <measurement group_id="B2" value="7839"/>
                    <measurement group_id="B4" value="15741"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4861"/>
                    <measurement group_id="B2" value="4924"/>
                    <measurement group_id="B4" value="9785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Apixaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4802"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4802"/>
                    <count group_id="B4" value="9604"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3028"/>
                    <measurement group_id="B3" value="3039"/>
                    <measurement group_id="B4" value="6067"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1774"/>
                    <measurement group_id="B3" value="1763"/>
                    <measurement group_id="B4" value="3537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Ethnicity information was not collected for this trial.</description>
          <population>The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="17177"/>
                    <count group_id="B3" value="12594"/>
                    <count group_id="B4" value="42534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3771"/>
                    <measurement group_id="B2" value="5388"/>
                    <measurement group_id="B3" value="3744"/>
                    <measurement group_id="B4" value="12903"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="358"/>
                    <measurement group_id="B3" value="272"/>
                    <measurement group_id="B4" value="932"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other/Unknown/Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8690"/>
                    <measurement group_id="B2" value="11431"/>
                    <measurement group_id="B3" value="8578"/>
                    <measurement group_id="B4" value="28699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Rivaroxaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12763"/>
                    <count group_id="B2" value="12763"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="25526"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3771"/>
                    <measurement group_id="B2" value="3779"/>
                    <measurement group_id="B4" value="7550"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B4" value="599"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other/Unknown/Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8690"/>
                    <measurement group_id="B2" value="8687"/>
                    <measurement group_id="B4" value="17377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs Apixaban (matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4802"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4802"/>
                    <count group_id="B4" value="9604"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1621"/>
                    <measurement group_id="B3" value="1622"/>
                    <measurement group_id="B4" value="3243"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B3" value="152"/>
                    <measurement group_id="B4" value="309"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other/Unknown/Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3024"/>
                    <measurement group_id="B3" value="3028"/>
                    <measurement group_id="B4" value="6052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stroke Overall (Hemorrhagic, Ischemic, Uncertain)</title>
        <description>The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:&#xD;
The day of discontinuation of the index NOAC exposure;&#xD;
The day before a switch to an anticoagulant different from the index exposure;&#xD;
The day before a change in dose for the index NOAC;&#xD;
The end of continuous eligibility of a patient in the health plan (disenrollment);&#xD;
The end of the study observation period; or&#xD;
The date of death of the patient.</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Overall (Hemorrhagic, Ischemic, Uncertain)</title>
          <description>The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:&#xD;
The day of discontinuation of the index NOAC exposure;&#xD;
The day before a switch to an anticoagulant different from the index exposure;&#xD;
The day before a change in dose for the index NOAC;&#xD;
The end of continuous eligibility of a patient in the health plan (disenrollment);&#xD;
The end of the study observation period; or&#xD;
The date of death of the patient.</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" lower_limit="0.41" upper_limit="0.66"/>
                    <measurement group_id="O2" value="0.69" lower_limit="0.56" upper_limit="0.84"/>
                    <measurement group_id="O3" value="0.46" lower_limit="0.28" upper_limit="0.70"/>
                    <measurement group_id="O4" value="0.36" lower_limit="0.21" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0844</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.766</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.566</ci_lower_limit>
            <ci_upper_limit>1.037</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4892</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.255</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.659</ci_lower_limit>
            <ci_upper_limit>2.390</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Major Bleeding</title>
        <description>The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Major Bleeding</title>
          <description>The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" lower_limit="1.60" upper_limit="2.05"/>
                    <measurement group_id="O2" value="2.24" lower_limit="2.00" upper_limit="2.49"/>
                    <measurement group_id="O3" value="1.69" lower_limit="1.33" upper_limit="2.11"/>
                    <measurement group_id="O4" value="1.24" lower_limit="0.94" upper_limit="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0182</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.696</ci_lower_limit>
            <ci_upper_limit>0.967</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0702</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.374</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.974</ci_lower_limit>
            <ci_upper_limit>1.939</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ischemic Stroke</title>
        <description>The event rate of ischemic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Ischemic Stroke</title>
          <description>The event rate of ischemic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.39" upper_limit="0.62"/>
                    <measurement group_id="O2" value="0.54" lower_limit="0.42" upper_limit="0.67"/>
                    <measurement group_id="O3" value="0.39" lower_limit="0.23" upper_limit="0.62"/>
                    <measurement group_id="O4" value="0.36" lower_limit="0.21" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6307</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.923</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.667</ci_lower_limit>
            <ci_upper_limit>1.278</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8777</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.054</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.540</ci_lower_limit>
            <ci_upper_limit>2.055</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemorrhagic Stroke</title>
        <description>The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Hemorrhagic Stroke</title>
          <description>The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="0.01" upper_limit="0.08"/>
                    <measurement group_id="O2" value="0.16" lower_limit="0.11" upper_limit="0.25"/>
                    <measurement group_id="O3" value="0.07" lower_limit="0.01" upper_limit="0.19"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">As there is no person with the event of interest in apixaban groups thus event rate and 95% CI is not calculated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0023</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.223</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.085</ci_lower_limit>
            <ci_upper_limit>0.585</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Intracranial Bleeding</title>
        <description>The event rate of major intracranial bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Major Intracranial Bleeding</title>
          <description>The event rate of major intracranial bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" lower_limit="0.19" upper_limit="0.37"/>
                    <measurement group_id="O2" value="0.41" lower_limit="0.31" upper_limit="0.53"/>
                    <measurement group_id="O3" value="0.24" lower_limit="0.12" upper_limit="0.43"/>
                    <measurement group_id="O4" value="0.21" lower_limit="0.10" upper_limit="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0406</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.654</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.435</ci_lower_limit>
            <ci_upper_limit>0.982</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8124</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.469</ci_lower_limit>
            <ci_upper_limit>2.630</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Extracranial Bleeding</title>
        <description>The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Major Extracranial Bleeding</title>
          <description>The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" lower_limit="1.35" upper_limit="1.76"/>
                    <measurement group_id="O2" value="1.83" lower_limit="1.62" upper_limit="2.07"/>
                    <measurement group_id="O3" value="1.44" lower_limit="1.12" upper_limit="1.84"/>
                    <measurement group_id="O4" value="1.03" lower_limit="0.76" upper_limit="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0901</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.856</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.716</ci_lower_limit>
            <ci_upper_limit>1.025</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0616</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.431</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.983</ci_lower_limit>
            <ci_upper_limit>2.083</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major GI Bleeding</title>
        <description>The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Major GI Bleeding</title>
          <description>The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" lower_limit="1.26" upper_limit="1.66"/>
                    <measurement group_id="O2" value="1.66" lower_limit="1.46" upper_limit="1.89"/>
                    <measurement group_id="O3" value="1.36" lower_limit="1.04" upper_limit="1.74"/>
                    <measurement group_id="O4" value="0.92" lower_limit="0.66" upper_limit="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2073</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.887</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.736</ci_lower_limit>
            <ci_upper_limit>1.069</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0417</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.504</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.015</ci_lower_limit>
            <ci_upper_limit>2.228</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Urogenital Bleeding</title>
        <description>The event rate of major urogenital bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Major Urogenital Bleeding</title>
          <description>The event rate of major urogenital bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">As there is no person with the event of interest for dabigatran in dabigatran vs rivaroxaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran.</measurement>
                    <measurement group_id="O2" value="0.01" lower_limit="0.00" upper_limit="0.04"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">As there is no person with the event of interest for dabigatran in dabigatran vs apixaban groups and also for the apixaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran and for apixaban.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">As there is no person with the event of interest for dabigatran in dabigatran vs apixaban groups and also for the apixaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran and for apixaban.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Other Bleeding</title>
        <description>The event rate of major other bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Major Other Bleeding</title>
          <description>The event rate of major other bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" lower_limit="0.08" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.18" lower_limit="0.12" upper_limit="0.26"/>
                    <measurement group_id="O3" value="0.11" lower_limit="0.04" upper_limit="0.25"/>
                    <measurement group_id="O4" value="0.13" lower_limit="0.05" upper_limit="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2663</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.709</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.387</ci_lower_limit>
            <ci_upper_limit>1.299</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8112</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.864</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.261</ci_lower_limit>
            <ci_upper_limit>2.863</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Upper GI Bleeding</title>
        <description>The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Upper GI Bleeding</title>
          <description>The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" lower_limit="0.31" upper_limit="0.52"/>
                    <measurement group_id="O2" value="0.55" lower_limit="0.44" upper_limit="0.69"/>
                    <measurement group_id="O3" value="0.37" lower_limit="0.22" upper_limit="0.59"/>
                    <measurement group_id="O4" value="0.34" lower_limit="0.19" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1227</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.766</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.546</ci_lower_limit>
            <ci_upper_limit>1.075</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7115</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.138</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.573</ci_lower_limit>
            <ci_upper_limit>2.260</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lower GI Bleeding</title>
        <description>The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>Lower GI Bleeding</title>
          <description>The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="0.91" upper_limit="1.26"/>
                    <measurement group_id="O2" value="1.17" lower_limit="1.00" upper_limit="1.36"/>
                    <measurement group_id="O3" value="0.98" lower_limit="0.72" upper_limit="1.32"/>
                    <measurement group_id="O4" value="0.58" lower_limit="0.38" upper_limit="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4727</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.923</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.741</ci_lower_limit>
            <ci_upper_limit>1.149</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0275</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.721</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.062</ci_lower_limit>
            <ci_upper_limit>2.790</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TIA</title>
        <description>The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>TIA</title>
          <description>The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.18" upper_limit="0.35"/>
                    <measurement group_id="O2" value="0.20" lower_limit="0.13" upper_limit="0.29"/>
                    <measurement group_id="O3" value="0.28" lower_limit="0.15" upper_limit="0.48"/>
                    <measurement group_id="O4" value="0.17" lower_limit="0.07" upper_limit="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2309</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.346</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.828</ci_lower_limit>
            <ci_upper_limit>2.189</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3333</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.557</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.635</ci_lower_limit>
            <ci_upper_limit>3.821</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality</title>
        <description>The event rate of all-cause mortality in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
        <time_frame>Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years</time_frame>
        <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (Dabigatran vs Rivaroxaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
          <group group_id="O4">
            <title>Apixaban (Dabigatran vs Apixaban)</title>
            <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>The event rate of all-cause mortality in patients matched on propensity scores without index year.&#xD;
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.&#xD;
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first</description>
          <population>Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).</population>
          <units>Event Rate in 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12763"/>
                <count group_id="O2" value="12763"/>
                <count group_id="O3" value="4802"/>
                <count group_id="O4" value="4802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" lower_limit="1.35" upper_limit="1.75"/>
                    <measurement group_id="O2" value="1.37" lower_limit="1.18" upper_limit="1.57"/>
                    <measurement group_id="O3" value="1.46" lower_limit="1.13" upper_limit="1.85"/>
                    <measurement group_id="O4" value="1.25" lower_limit="0.96" upper_limit="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9359</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.008</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.829</ci_lower_limit>
            <ci_upper_limit>1.226</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8947</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.024</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.716</ci_lower_limit>
            <ci_upper_limit>1.465</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>This is a retrospective observational study, in which all patient data were de-identified and analyzed in aggregate. Individual patient safety related information were not captured during this study. Thus, individual safety reporting (including adverse events reporting) was not applicable for this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran</title>
          <description>Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran.</description>
        </group>
        <group group_id="E2">
          <title>Rivaroxaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban.</description>
        </group>
        <group group_id="E3">
          <title>Apixaban</title>
          <description>OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03026556
org study id: 1160-0274
nct id: NCT03026556
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and effectiveness of newly initiated
      dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in
      comparison to newly initiated rivaroxaban users and newly initiated apixaban users
observational model: Cohort
time perspective: Retrospective
measure: Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:
The day of discontinuation of the index NOAC exposure;
The day before a switch to an anticoagulant different from the index exposure;
The day before a change in dose for the index NOAC;
The end of continuous eligibility of a patient in the health plan (disenrollment);
The end of the study observation period; or
The date of death of the patient.
measure: Overall Major Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
measure: Ischemic Stroke
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of ischemic stroke in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Hemorrhagic Stroke
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
measure: Major Intracranial Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of major intracranial bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Major Extracranial Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Major GI Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Major Urogenital Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of major urogenital bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
measure: Major Other Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of major other bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Upper GI Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: Lower GI Bleeding
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: TIA
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
measure: All-cause Mortality
time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
description: The event rate of all-cause mortality in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
arm group label: Dabigatran vs. Rivaroxaban
description: OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).
arm group label: Dabigatran vs. Apixaban
description: OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).
intervention type: Drug
intervention name: Dabigatran vs. Rivaroxaban
description: observed for 6 years
arm group label: Dabigatran vs. Rivaroxaban
intervention type: Drug
intervention name: Dabigatran vs. Apixaban
description: Observed for 6 years
arm group label: Dabigatran vs. Apixaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Rivaroxaban
mesh term: Apixaban
mesh term: Dabigatran
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 