<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/NCT02197416</url>
  </required_header>
  <id_info>
    <org_study_id>1160.108</org_study_id>
    <secondary_id>2014-000583-18</secondary_id>
    <nct_id>NCT02197416</nct_id>
  </id_info>
  <brief_title>Safety of Dabigatran Etexilate in Blood Clot Prevention in Children</brief_title>
  <official_title>Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This open-label, single arm prospective cohort study will assess the safety of dabigatran&#xD;
      etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children&#xD;
      from 0 to less than 18 years of age will be eligible to participate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2014</start_date>
  <completion_date type="Actual">November 19, 2019</completion_date>
  <primary_completion_date type="Actual">October 16, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months</measure>
    <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
    <description>The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months</measure>
    <time_frame>At month 6 (Week 26) and month 12 (Week 52) of on treatment period</time_frame>
    <description>The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months</measure>
    <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
    <description>The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months</measure>
    <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
    <description>The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period</measure>
    <time_frame>From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days</time_frame>
    <description>Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</measure>
    <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</measure>
    <time_frame>Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</measure>
    <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</measure>
    <time_frame>Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</measure>
    <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</measure>
    <time_frame>dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Secondary Prevention</condition>
  <arm_group>
    <arm_group_label>dabigatran etexilate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dabigatran etexilate</intervention_name>
    <description>Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation</description>
    <arm_group_label>dabigatran etexilate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male or female subjects 0 to less than 18 years of age at the time of informed consent&#xD;
             / assent&#xD;
&#xD;
          -  Previously documented objective diagnosis of VTE, followed by completed course of&#xD;
             initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2&#xD;
             and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial.&#xD;
             Patients, who during the treatment phase of 1160.106 trial were switched from&#xD;
             dabigatran etexilate to SOC arm for any reason, are not eligible for this study.&#xD;
&#xD;
          -  Presence of an unresolved clinical risk factor requiring further anticoagulation for&#xD;
             secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia,&#xD;
             etc.)&#xD;
&#xD;
          -  Written informed consent form (ICF) provided by the patient's parent or legal guardian&#xD;
             and assent provided by the patient (if applicable) at the time of ICF signature&#xD;
             according to local regulations.&#xD;
&#xD;
          -  Further inclusion criteria apply&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Conditions associated with an increased risk of bleeding&#xD;
&#xD;
          -  Renal dysfunction (eGFR &lt; 50 mL/min/1.73m^2 using the Schwartz formula) or requirement&#xD;
             for dialysis. eGFR retesting during the screening period is allowed (once).&#xD;
&#xD;
          -  Active infective endocarditis&#xD;
&#xD;
          -  Subjects with a heart valve prosthesis requiring anticoagulation.&#xD;
&#xD;
          -  Hepatic disease: Active liver disease, including known active hepatitis A, B or C or&#xD;
             Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline&#xD;
             phosphatase (AP) &gt; 3 × upper limit of normal (ULN) within 3 months of screening&#xD;
&#xD;
          -  Pregnant or breast feeding females. Females who have reached menarche and are not&#xD;
             using an acceptable method of birth control, or do not plan to continue using this&#xD;
             method throughout the study and / or do not agree to adhere to pregnancy testing&#xD;
             required by this protocol&#xD;
&#xD;
          -  Patients in age group 0 to &lt; 2 years with gestational age at birth &lt; 37 weeks or with&#xD;
             body weight lower than the 3rd percentile&#xD;
&#xD;
          -  Anemia (hemoglobin &lt; 80g/L) or thrombocytopenia (platelet count &lt; 80 x 109/L) at&#xD;
             screening. Transfusions during the screening period are allowed, provided that a&#xD;
             satisfactory hemoglobin or platelet level is attained prior to visit 2&#xD;
&#xD;
          -  Patients who have taken restricted medication prior to first dose of study medication&#xD;
&#xD;
          -  Patients who have received an investigational drug in the past 30 days prior to&#xD;
             screening, except patients who have completed the treatment period (up to Visit 8) in&#xD;
             1160.106 trial&#xD;
&#xD;
          -  Patients who are allergic/sensitive to any component of the study medication including&#xD;
             solvent&#xD;
&#xD;
          -  Patients or parents/legal guardians considered unreliable to participate in the trial&#xD;
             per investigator judgment or any condition which would present a safety hazard to the&#xD;
             patient based on investigator judgment&#xD;
&#xD;
          -  Further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</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>
      <name>University of California Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Children's Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-1083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center and Children's Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medical University of Vienna</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brussels - UNIV UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIV UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas</name>
      <address>
        <city>Campinas</city>
        <zip>13059-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Ciencias Medicas da UNICAMP</name>
      <address>
        <city>Campinas</city>
        <zip>13083970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04039-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Ontario</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <zip>61300</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>77900</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plzen, Plzen-Lochotin</name>
      <address>
        <city>Plzen - Lochotin</city>
        <zip>304 60</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Prague</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet, København, Børneonkologisk Afsnit 5002</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen AöR</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen, Georg-August-Universität</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Debrecen Hospital</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center, Jerusalem 91031</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Univ. Policlinico &quot;Paolo Giaccone&quot;</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi &quot;La Sapienza&quot;</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. Pediatrico Bambin Gesù</name>
      <address>
        <city>Roma</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius</name>
      <address>
        <city>Vilnius</city>
        <zip>08406</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Pediatría</name>
      <address>
        <city>Mexico DF</city>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssykehus</name>
      <address>
        <city>Bergen</city>
        <zip>N-5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus HF, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>N-0372</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan</name>
      <address>
        <city>Kazan</city>
        <zip>420138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow</name>
      <address>
        <city>Moscow</city>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol</name>
      <address>
        <city>Moscow</city>
        <zip>125373</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Petersburg State Pediatric Univ.Ministry of Healthcare RF</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery</name>
      <address>
        <city>Tyument</city>
        <zip>625023</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Healthcare Institution &quot;Republican children's clinical hospital&quot;</name>
      <address>
        <city>Ufa</city>
        <zip>450106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childr.CityClin.Hos#9,pediatric&amp;Neonatal Neurol.Ekaterinburg</name>
      <address>
        <city>Yekaterinburg</city>
        <zip>620134</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Univ. sjukhuset</name>
      <address>
        <city>Solna</city>
        <zip>171 65</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Kinderspital</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cukurova Universitesi Tip Fakultesi Cocuk Sagligi</name>
      <address>
        <city>Adana</city>
        <zip>1330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe Universitesi Tip Fakultesi</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akdeniz Universitesi Tip Fakultesi</name>
      <address>
        <city>Antalya</city>
        <zip>7058</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Necmettin Erbakan Universitesi Meram Tip Fakultesi</name>
      <address>
        <city>Konya</city>
        <zip>42080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reg.Children Hosp.Dnipropetrovsk</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49100</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Ukrainian Spec.Children Med.Center,Lviv</name>
      <address>
        <city>Lviv</city>
        <zip>79035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reg.Children Hosp,Vinnytsia</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Norway</country>
    <country>Russian Federation</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Colombia</country>
    <country>Czech Republic</country>
    <country>Finland</country>
    <country>Greece</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>May 7, 2020</results_first_submitted>
  <results_first_submitted_qc>May 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2020</results_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>Neoplasm Metastasis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dabigatran</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>February 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02197416/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>March 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02197416/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This open label, single arm prospective cohort study was designed to assess the safety of dabigatran etexilate (DE) for secondary prevention of paediatric venous thromboembolism (VTE) with 12-month (365 days) treatment period followed by 28 days end of treatment follow-up. Results of participants were reported via 3 mutually exclusive age groups.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. 1 enrolled subject was withdrawn before treated due to unable to swallow the capsules.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
          <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
        </group>
        <group group_id="P2">
          <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
          <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
        </group>
        <group group_id="P3">
          <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
          <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
          <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
        </group>
        <group group_id="B2">
          <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
          <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
        </group>
        <group group_id="B3">
          <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
          <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</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="9"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="161"/>
            <count group_id="B4" value="213"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" spread="0.5"/>
                    <measurement group_id="B2" value="6.8" spread="3.1"/>
                    <measurement group_id="B3" value="15.1" spread="1.6"/>
                    <measurement group_id="B4" value="12.8" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="91"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="153"/>
                    <measurement group_id="B4" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months</title>
        <description>The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
        <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
        <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months</title>
          <description>The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
          <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
          <units>Probability</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="9"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="0.979" lower_limit="0.937" upper_limit="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="0.979" lower_limit="0.937" upper_limit="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months</title>
        <description>The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
        <time_frame>At month 6 (Week 26) and month 12 (Week 52) of on treatment period</time_frame>
        <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months</title>
          <description>The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
          <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
          <units>Probability</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="9"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.889" lower_limit="0.433" upper_limit="0.984"/>
                    <measurement group_id="O2" value="0.894" lower_limit="0.706" upper_limit="0.965"/>
                    <measurement group_id="O3" value="0.753" lower_limit="0.675" upper_limit="0.815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.889" lower_limit="0.433" upper_limit="0.984"/>
                    <measurement group_id="O2" value="0.831" lower_limit="0.592" upper_limit="0.936"/>
                    <measurement group_id="O3" value="0.691" lower_limit="0.603" upper_limit="0.763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months</title>
        <description>The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
        <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
        <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months</title>
          <description>The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.&#xD;
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
          <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
          <units>Probability</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="9"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months</title>
        <description>The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
        <time_frame>At month 6 (Week 26) and 12 (Week 52) of on treatment period</time_frame>
        <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months</title>
          <description>The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
          <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
          <units>Probability</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="9"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="0.979" lower_limit="0.935" upper_limit="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.000" upper_limit="1.000"/>
                    <measurement group_id="O3" value="0.979" lower_limit="0.935" upper_limit="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period</title>
        <description>Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
        <time_frame>From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days</time_frame>
        <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period</title>
          <description>Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.</description>
          <population>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.</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="9"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="39.5"/>
                    <measurement group_id="O3" value="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
        <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
        <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
          <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" spread="18.1"/>
                    <measurement group_id="O2" value="57.1" spread="70.4"/>
                    <measurement group_id="O3" value="56.8" spread="64.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
        <time_frame>Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
        <population>The PD set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
          <population>The PD set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" spread="26.8"/>
                    <measurement group_id="O2" value="57.3" spread="23.9"/>
                    <measurement group_id="O3" value="59.0" spread="80.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
        <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
        <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
          <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.7" spread="17.6"/>
                    <measurement group_id="O2" value="64.3" spread="55.7"/>
                    <measurement group_id="O3" value="69.5" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
        <time_frame>Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
        <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
          <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3" spread="19.4"/>
                    <measurement group_id="O2" value="66.6" spread="23.6"/>
                    <measurement group_id="O3" value="69.2" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
        <time_frame>At Visit 3 (day 4 after first dose of trial medication)</time_frame>
        <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)</title>
          <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.9" spread="19.5"/>
                    <measurement group_id="O2" value="40.5" spread="14.6"/>
                    <measurement group_id="O3" value="45.3" spread="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
        <time_frame>dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.</time_frame>
        <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate (0 to &lt; 2 Years)</title>
            <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 0 to &lt;2 years.</description>
          </group>
          <group group_id="O2">
            <title>Dabigatran Etexilate (2 to &lt;12 Years)</title>
            <description>Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and &lt;12 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 2 to &lt; 12 years.</description>
          </group>
          <group group_id="O3">
            <title>Dabigatran Etexilate (12 to &lt;18 Years)</title>
            <description>Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.&#xD;
This arm includes participants aged between 12 to &lt;18 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)</title>
          <population>The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.</population>
          <units>Second (s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" spread="24.3"/>
                    <measurement group_id="O2" value="46.0" spread="18.6"/>
                    <measurement group_id="O3" value="43.4" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.</time_frame>
      <desc>The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran Etexilate (Treated Set)</title>
          <description>Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.&#xD;
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.&#xD;
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.&#xD;
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and &lt;250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.1</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="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ventricular pre-excitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital anomaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic vein stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Metal poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute lymphocytic leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ewing's sarcoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstrual disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pelvic adhesions</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lupus vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Phlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="113" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="213"/>
              </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/NCT02197416
org study id: 1160.108
secondary id: 2014-000583-18
nct id: NCT02197416
lead sponsor: 
This open-label, single arm prospective cohort study will assess the safety of dabigatran
      etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children
      from 0 to less than 18 years of age will be eligible to participate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
description: The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
measure: Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
time frame: At month 6 (Week 26) and month 12 (Week 52) of on treatment period
description: The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
measure: Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
description: The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
measure: Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
description: The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
measure: Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period
time frame: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days
description: Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
measure: Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
time frame: At Visit 3 (day 4 after first dose of trial medication)
measure: Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
time frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
measure: Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
time frame: At Visit 3 (day 4 after first dose of trial medication)
measure: Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
time frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
measure: Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
time frame: At Visit 3 (day 4 after first dose of trial medication)
measure: Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
time frame: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
arm group label: dabigatran etexilate
arm group type: Experimental
intervention type: Drug
intervention name: dabigatran etexilate
description: Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
arm group label: dabigatran etexilate
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Austria
country: Belgium
country: Brazil
country: Canada
country: Czechia
country: Denmark
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Lithuania
country: Mexico
country: Norway
country: Russian Federation
country: Sweden
country: Switzerland
country: Taiwan
country: Thailand
country: Turkey
country: Ukraine
country: United States
country: Argentina
country: Bulgaria
country: Colombia
country: Czech Republic
country: Finland
country: Greece
country: Slovakia
country: Spain
country: United Kingdom
url: https://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Dabigatran
provided document: 
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point of contact: 