<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/NCT02240667</url>
  </required_header>
  <id_info>
    <org_study_id>1160.218</org_study_id>
    <nct_id>NCT02240667</nct_id>
  </id_info>
  <brief_title>Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)</brief_title>
  <official_title>Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12&#xD;
      months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for&#xD;
      definitive treatment discontinuation will be collected. At 6 months, patient adherence will&#xD;
      be assessed, using the Morisky Score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2014</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month</measure>
    <time_frame>12 month (Visit 5)</time_frame>
    <description>Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.</measure>
    <time_frame>6 month (visit 3)</time_frame>
    <description>Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and &gt; 2, respectively).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With the Reason for Definitive Treatment Discontinuation</measure>
    <time_frame>Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)</time_frame>
    <description>Number of patients with the reason for definitive treatment discontinuation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1506</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Subjects with atrial fibrillation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran etexilate</intervention_name>
    <description>150 mg or 110 mg capsules twice daily</description>
    <arm_group_label>Subjects with atrial fibrillation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin K antagonists</intervention_name>
    <description>International Normalized Ratio (INR) 2-3</description>
    <arm_group_label>Subjects with atrial fibrillation</arm_group_label>
    <other_name>Phenprocoumon</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        AF patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication&#xD;
             &quot;Stroke prevention in non-valvular atrial fibrillation&quot; (AF) respecting the indication&#xD;
             and contraindications as described in the respective Summary of Product&#xD;
             Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA&#xD;
             (patients are eligible for both Pradaxa® and VKA therapy).&#xD;
&#xD;
          -  Treatment with dabigatran etexilate or VKA is given in accordance with the respective&#xD;
             Summaries of Product Characteristics. The routine diagnostic procedures and treatment&#xD;
             that would be undertaken irrespective of the study are unaffected.&#xD;
&#xD;
          -  Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA&#xD;
             in accordance with the respective Summaries of Product Characteristics will be&#xD;
             documented (patients eligible for VKA and Pradaxa®)&#xD;
&#xD;
          -  Patients must have signed the patient consent form prior to inclusion in the&#xD;
             Non-Interventional Study (NIS).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with the general and special contraindications mentioned in the packaging&#xD;
             leaflet or Summary of Product Characteristics must not be included.&#xD;
&#xD;
          -  Patients participating at the same time or within the last 30 days in another&#xD;
             Non-Interventional Study (NIS) or an interventional clinical trial must not be&#xD;
             included.&#xD;
&#xD;
          -  Patients treated with anticoagulants for a condition other than non-valvular atrial&#xD;
             fibrillation must not be included.&#xD;
&#xD;
          -  Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or&#xD;
             breastfeeding women must therefore not be included in the NIS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>December 20, 2018</results_first_submitted>
  <results_first_submitted_qc>April 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2019</results_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 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>Vitamin K</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Phenprocoumon</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 4, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02240667/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02240667/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In this study 1506 patients were entered, 1421 patients had at least one documented prescription of dabigatran etexilate (DE) or vitamin K antagonists (VKA)and were analyzed in the Treated set. 952 patients were matched 1:1 based on Propensity Score (PS).</recruitment_details>
      <pre_assignment_details>The patients were enrolled from 1000 sites from Germany. Approximately 2/3 (about 670) will be community-based primary care internists/general practitioners and approximately 1/3 (about 330) community-based cardiologists across Germany.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran (Dabigatran vs VKA)</title>
          <description>Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
        <group group_id="P2">
          <title>Vitamin K Antagonists (VKA)</title>
          <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="771"/>
                <participants group_id="P2" count="650"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="771"/>
                <participants group_id="P2" count="650"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF (=IC 2) with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint).</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran (Dabigatran vs VKA)</title>
          <description>Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
        <group group_id="B2">
          <title>Vitamin K Antagonists (VKA)</title>
          <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
        <group group_id="B3">
          <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="771"/>
            <count group_id="B2" value="650"/>
            <count group_id="B3" value="1421"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>TS</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="771"/>
                    <count group_id="B2" value="650"/>
                    <count group_id="B3" value="1421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75" lower_limit="23" upper_limit="96"/>
                    <measurement group_id="B2" value="75" lower_limit="38" upper_limit="96"/>
                    <measurement group_id="B3" value="75" lower_limit="23" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs VKA(matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="476"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="952"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75" lower_limit="40" upper_limit="96"/>
                    <measurement group_id="B2" value="75" lower_limit="38" upper_limit="96"/>
                    <measurement group_id="B3" value="75" lower_limit="38" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>TS</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="771"/>
                    <count group_id="B2" value="650"/>
                    <count group_id="B3" value="1421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="284"/>
                    <measurement group_id="B3" value="623"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="432"/>
                    <measurement group_id="B2" value="366"/>
                    <measurement group_id="B3" value="798"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dabigatran vs VKA(matched pop)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="476"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="952"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="419"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="262"/>
                    <measurement group_id="B2" value="271"/>
                    <measurement group_id="B3" value="533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <description>Race and Ethnicity was not reported in this trial</description>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month</title>
        <description>Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.</description>
        <time_frame>12 month (Visit 5)</time_frame>
        <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
          <group group_id="O2">
            <title>VKA (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month</title>
          <description>Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.</description>
          <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
          <units>percentage of participants</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="476"/>
                <count group_id="O2" value="476"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5" lower_limit="86.3" upper_limit="91.9"/>
                    <measurement group_id="O2" value="89.5" lower_limit="86.3" upper_limit="92.0"/>
                  </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>Persistence in both treatment groups was compared by means of the stratified Log-rank test</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8496</p_value>
            <method>stratified log-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.</title>
        <description>Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and &gt; 2, respectively).</description>
        <time_frame>6 month (visit 3)</time_frame>
        <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
          <group group_id="O2">
            <title>VKA (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.</title>
          <description>Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and &gt; 2, respectively).</description>
          <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="476"/>
                <count group_id="O2" value="476"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.12"/>
                    <measurement group_id="O2" value="23.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8"/>
                    <measurement group_id="O2" value="46.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.88"/>
                    <measurement group_id="O2" value="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2"/>
                    <measurement group_id="O2" value="25.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With the Reason for Definitive Treatment Discontinuation</title>
        <description>Number of patients with the reason for definitive treatment discontinuation</description>
        <time_frame>Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)</time_frame>
        <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
          <group group_id="O2">
            <title>VKA (Dabigatran vs VKA)</title>
            <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With the Reason for Definitive Treatment Discontinuation</title>
          <description>Number of patients with the reason for definitive treatment discontinuation</description>
          <population>Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="476"/>
                <count group_id="O2" value="476"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Month 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient's wish</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decision of physician</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Month 6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient's wish</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decision of physician</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Month 9)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient's wish</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decision of physician</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Month 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient's wish</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decision of physician</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of treatment until six days after permanent treatment discontinuation or end of study, up to 12 months.</time_frame>
      <desc>The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint). Treatment emergent Adverse events were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran (Dabigatran vs VKA)</title>
          <description>Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
        <group group_id="E2">
          <title>Vitamin K Antagonists (VKA)</title>
          <description>Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Mitral valve disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Optic ischaemic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Papilla of Vater stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram change</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Cerebral microangiopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Chorea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Mediastinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="771"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="650"/>
              </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="771"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="650"/>
              </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/NCT02240667
org study id: 1160.218
nct id: NCT02240667
lead sponsor: 
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12
      months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for
      definitive treatment discontinuation will be collected. At 6 months, patient adherence will
      be assessed, using the Morisky Score.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
time frame: 12 month (Visit 5)
description: Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.
measure: Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
time frame: 6 month (visit 3)
description: Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively).
measure: Number of Patients With the Reason for Definitive Treatment Discontinuation
time frame: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)
description: Number of patients with the reason for definitive treatment discontinuation
arm group label: Subjects with atrial fibrillation
intervention type: Drug
intervention name: Dabigatran etexilate
description: 150 mg or 110 mg capsules twice daily
arm group label: Subjects with atrial fibrillation
intervention type: Drug
intervention name: Vitamin K antagonists
description: International Normalized Ratio (INR) 2-3
arm group label: Subjects with atrial fibrillation
other name: Phenprocoumon
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Vitamin K
mesh term: Dabigatran
mesh term: Phenprocoumon
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 