<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/NCT02981472</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-362</org_study_id>
    <secondary_id>2016-001247-39</secondary_id>
    <nct_id>NCT02981472</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation</brief_title>
  <official_title>A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pediatric Heart Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the safety and pharmacokinetics of apixaban in children with congenital or&#xD;
      acquired heart disease who have a need for anticoagulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">October 18, 2021</completion_date>
  <primary_completion_date type="Actual">October 18, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.&#xD;
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death</measure>
    <time_frame>From randomization to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.&#xD;
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Adjudicated Major Bleeding</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:&#xD;
fatal bleeding&#xD;
clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period&#xD;
bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS&#xD;
bleeding that requires surgical intervention in an operating suite, including interventional radiology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Adjudicated CRNM Bleeding</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:&#xD;
overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition&#xD;
bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With All Adjudicated Bleeding</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with all adjudicated bleeding events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participant Deaths in the Study</measure>
    <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
    <description>The number of participant deaths in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax)</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Observed Concentration (Cmin)</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Observed Concentration (Tmax)</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-FXa Activity</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
    <description>Anti-FXa Activity was measured to assess participant plasma apixaban levels.&#xD;
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chromogenic FX Assay (Apparent FX Level)</measure>
    <time_frame>From first dose up to 6 months after first dose</time_frame>
    <description>Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.&#xD;
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)</measure>
    <time_frame>from randomization up to 12 months after randomization</time_frame>
    <description>Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).&#xD;
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score</measure>
    <time_frame>from randomization up to 12 months after randomization</time_frame>
    <description>Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LMWH/VKA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Apixaban</arm_group_label>
    <other_name>Eliquis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin K Antagonist (VKA)</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>LMWH/VKA</arm_group_label>
    <other_name>Warfarin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Molecular Weight Heparin (LMWH)</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>LMWH/VKA</arm_group_label>
    <other_name>Enoxaparin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and Females, 28 days to &lt; 18 years of age, inclusive&#xD;
&#xD;
          -  Congenital or acquired heart diseases requiring chronic anticoagulation for&#xD;
             thromboprophylaxis (eg, single ventricle physiology including all 3 stages of&#xD;
             palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and&#xD;
             pulmonary hypertension)&#xD;
&#xD;
          -  Eligible participants include those who newly start anticoagulants and those who are&#xD;
             currently on VKA or LMWH or other anticoagulants for thromboprophylaxis&#xD;
&#xD;
          -  Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]&#xD;
&#xD;
          -  Participants 28 days to &lt; 3 months must be able to tolerate oral/nasogastric tube&#xD;
             (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent thromboembolic events less than 6 months prior to enrollment&#xD;
&#xD;
          -  Weight &lt; 3 kg&#xD;
&#xD;
          -  Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or&#xD;
             extracorporeal membrane oxygenation (ECMO) at the time of enrollment&#xD;
&#xD;
          -  Artificial heart valves and mechanical heart valves&#xD;
&#xD;
          -  Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand&#xD;
             disease, etc.)&#xD;
&#xD;
          -  Active bleeding at the time of enrollment&#xD;
&#xD;
          -  Any major bleeding other than perioperative in the preceding 3 months&#xD;
&#xD;
          -  Known intracranial congenital vascular malformation or tumor&#xD;
&#xD;
          -  Confirmed diagnosis of a GI ulcer&#xD;
&#xD;
          -  Known antiphospholipid syndrome (APS).&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children'S Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0641</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children'S Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Healthcare Of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0013</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital Of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-2399</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0055</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80250-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto De Cardiologia Do Rio Grande Do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90620-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13060-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisa PENSI</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01227-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal De Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0015</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>HUS</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0004</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0003</name>
      <address>
        <city>Muenchen</city>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0047</name>
      <address>
        <city>Petach Tikva</city>
        <zip>0</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0046</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52620</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Milano</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0016</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0044</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620134</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0057</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0049</name>
      <address>
        <city>Barcelona</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0040</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>Bristol</city>
        <state>Somerset</state>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>April 7, 2022</results_first_submitted>
  <results_first_submitted_qc>May 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2022</results_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</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>Heart Diseases</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Apixaban</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02981472/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>192 participants were randomized and 188 received treatment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Apixaban</title>
          <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
        </group>
        <group group_id="P2">
          <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
          <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="119"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Apixaban</title>
          <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
        </group>
        <group group_id="B2">
          <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
          <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="129"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="192"/>
          </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="7.96" spread="4.553"/>
                    <measurement group_id="B2" value="7.56" spread="4.408"/>
                    <measurement group_id="B3" value="7.83" spread="4.499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>28 DAYS - &lt; 2 YEARS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 YEARS - &lt; 6 YEARS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 YEARS - &lt; 12 YEARS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>12 YEARS - &lt; 18 YEARS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="47"/>
                  </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="67"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="102"/>
                  </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="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events</title>
        <description>The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.&#xD;
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events</title>
          <description>The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.&#xD;
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death</title>
        <description>The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.&#xD;
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)</description>
        <time_frame>From randomization to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death</title>
          <description>The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.&#xD;
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)</description>
          <population>All randomized participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Thromboembolic event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thromboembolic event-related death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Adjudicated Major Bleeding</title>
        <description>The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:&#xD;
fatal bleeding&#xD;
clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period&#xD;
bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS&#xD;
bleeding that requires surgical intervention in an operating suite, including interventional radiology</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Adjudicated Major Bleeding</title>
          <description>The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:&#xD;
fatal bleeding&#xD;
clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period&#xD;
bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS&#xD;
bleeding that requires surgical intervention in an operating suite, including interventional radiology</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Adjudicated CRNM Bleeding</title>
        <description>The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:&#xD;
overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition&#xD;
bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Adjudicated CRNM Bleeding</title>
          <description>The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).&#xD;
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:&#xD;
overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition&#xD;
bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With All Adjudicated Bleeding</title>
        <description>The number of participants with all adjudicated bleeding events</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With All Adjudicated Bleeding</title>
          <description>The number of participants with all adjudicated bleeding events</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding</title>
        <description>The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding</title>
          <description>The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participant Deaths in the Study</title>
        <description>The number of participant deaths in the study.</description>
        <time_frame>From first dose to 2 days after last dose (Up to approximately 12 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participant Deaths in the Study</title>
          <description>The number of participant deaths in the study.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax)</title>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Weight Range 6 to &lt; 9 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 6 to &lt; 9 kg will be administered 1mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Participants Weight Range 9 to &lt; 12 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 9 to &lt; 12 kg will be administered 1.5mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>Participants Weight Range 12 to &lt; 18 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 12 to &lt; 18 kg will be administered 2mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O4">
            <title>Participants Weight Range 18 to &lt; 25 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 18 to &lt; 25 kg will be administered 3mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O5">
            <title>Participants Weight Range 25 to &lt; 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 25 to &lt; 35 kg will be administered 4mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O6">
            <title>Participants Weight Range ≥ 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between ≥ 35 kg will be administered 5mg apixaban twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax)</title>
          <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185" spread="48.8"/>
                    <measurement group_id="O2" value="218" spread="23.4"/>
                    <measurement group_id="O3" value="222" spread="39.6"/>
                    <measurement group_id="O4" value="244" spread="30.7"/>
                    <measurement group_id="O5" value="249" spread="37.7"/>
                    <measurement group_id="O6" value="203" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Observed Concentration (Cmin)</title>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Weight Range 6 to &lt; 9 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 6 to &lt; 9 kg will be administered 1mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Participants Weight Range 9 to &lt; 12 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 9 to &lt; 12 kg will be administered 1.5mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>Participants Weight Range 12 to &lt; 18 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 12 to &lt; 18 kg will be administered 2mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O4">
            <title>Participants Weight Range 18 to &lt; 25 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 18 to &lt; 25 kg will be administered 3mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O5">
            <title>Participants Weight Range 25 to &lt; 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 25 to &lt; 35 kg will be administered 4mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O6">
            <title>Participants Weight Range ≥ 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between ≥ 35 kg will be administered 5mg apixaban twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Observed Concentration (Cmin)</title>
          <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9" spread="90.3"/>
                    <measurement group_id="O2" value="82.7" spread="21.5"/>
                    <measurement group_id="O3" value="64.3" spread="69.5"/>
                    <measurement group_id="O4" value="67.4" spread="58.9"/>
                    <measurement group_id="O5" value="73.1" spread="64.7"/>
                    <measurement group_id="O6" value="72.7" spread="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))</title>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Weight Range 6 to &lt; 9 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 6 to &lt; 9 kg will be administered 1mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Participants Weight Range 9 to &lt; 12 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 9 to &lt; 12 kg will be administered 1.5mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>Participants Weight Range 12 to &lt; 18 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 12 to &lt; 18 kg will be administered 2mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O4">
            <title>Participants Weight Range 18 to &lt; 25 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 18 to &lt; 25 kg will be administered 3mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O5">
            <title>Participants Weight Range 25 to &lt; 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 25 to &lt; 35 kg will be administered 4mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O6">
            <title>Participants Weight Range ≥ 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between ≥ 35 kg will be administered 5mg apixaban twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))</title>
          <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
          <units>ng • h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1460" spread="61.2"/>
                    <measurement group_id="O2" value="1840" spread="20.7"/>
                    <measurement group_id="O3" value="1610" spread="49.6"/>
                    <measurement group_id="O4" value="1760" spread="38.3"/>
                    <measurement group_id="O5" value="1840" spread="43.3"/>
                    <measurement group_id="O6" value="1630" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Concentration (Tmax)</title>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Weight Range 6 to &lt; 9 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 6 to &lt; 9 kg will be administered 1mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Participants Weight Range 9 to &lt; 12 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 9 to &lt; 12 kg will be administered 1.5mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>Participants Weight Range 12 to &lt; 18 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 12 to &lt; 18 kg will be administered 2mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O4">
            <title>Participants Weight Range 18 to &lt; 25 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 18 to &lt; 25 kg will be administered 3mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O5">
            <title>Participants Weight Range 25 to &lt; 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between 25 to &lt; 35 kg will be administered 4mg apixaban twice daily (BID).</description>
          </group>
          <group group_id="O6">
            <title>Participants Weight Range ≥ 35 kg</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between ≥ 35 kg will be administered 5mg apixaban twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Concentration (Tmax)</title>
          <population>All treated participants in the apixaban arm with available pharmacokinetic data</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" lower_limit="1.41" upper_limit="2.83"/>
                    <measurement group_id="O2" value="2.47" lower_limit="2.23" upper_limit="2.71"/>
                    <measurement group_id="O3" value="1.72" lower_limit="0.938" upper_limit="3.35"/>
                    <measurement group_id="O4" value="1.74" lower_limit="0.775" upper_limit="2.18"/>
                    <measurement group_id="O5" value="1.65" lower_limit="1.26" upper_limit="2.85"/>
                    <measurement group_id="O6" value="1.85" lower_limit="1.47" upper_limit="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-FXa Activity</title>
        <description>Anti-FXa Activity was measured to assess participant plasma apixaban levels.&#xD;
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.</description>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm that have anti-FXa samples collected</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-FXa Activity</title>
          <description>Anti-FXa Activity was measured to assess participant plasma apixaban levels.&#xD;
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.</description>
          <population>All treated participants in the apixaban arm that have anti-FXa samples collected</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (4 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.69" spread="7.243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (PREDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.24" spread="7.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (2 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242.34" spread="18.966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (2 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.88" spread="14.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (PREDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.93" spread="6.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chromogenic FX Assay (Apparent FX Level)</title>
        <description>Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.&#xD;
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.</description>
        <time_frame>From first dose up to 6 months after first dose</time_frame>
        <population>All treated participants in the apixaban arm that have have chromogenic FX assay samples collected</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Chromogenic FX Assay (Apparent FX Level)</title>
          <description>Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.&#xD;
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.</description>
          <population>All treated participants in the apixaban arm that have have chromogenic FX assay samples collected</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (PREDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.87" spread="2.368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (4 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.90" spread="1.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (PREDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.88" spread="1.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (2 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.26" spread="1.680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (2 HRS POSTDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.25" spread="0.970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (PREDOSE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.57" spread="1.943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)</title>
        <description>Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).&#xD;
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.</description>
        <time_frame>from randomization up to 12 months after randomization</time_frame>
        <population>All randomized English speaking participants 2 years and older with both baseline and post baseline questionnaire scores</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)</title>
          <description>Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).&#xD;
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.</description>
          <population>All randomized English speaking participants 2 years and older with both baseline and post baseline questionnaire scores</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.64" spread="15.512"/>
                    <measurement group_id="O2" value="60.71" spread="17.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.37" spread="19.998"/>
                    <measurement group_id="O2" value="64.81" spread="22.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.61" spread="16.625"/>
                    <measurement group_id="O2" value="65.42" spread="18.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.00" spread="19.560"/>
                    <measurement group_id="O2" value="70.32" spread="21.949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.34" spread="22.130"/>
                    <measurement group_id="O2" value="64.70" spread="18.465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.46" spread="21.119"/>
                    <measurement group_id="O2" value="63.44" spread="19.836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT II ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.39" spread="22.994"/>
                    <measurement group_id="O2" value="85.68" spread="15.857"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT II ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.77" spread="10.896"/>
                    <measurement group_id="O2" value="86.27" spread="16.400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.51" spread="27.477"/>
                    <measurement group_id="O2" value="78.44" spread="23.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.56" spread="22.408"/>
                    <measurement group_id="O2" value="81.37" spread="30.689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT ANXIETY ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.52" spread="23.420"/>
                    <measurement group_id="O2" value="60.31" spread="34.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT ANXIETY ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.71" spread="25.480"/>
                    <measurement group_id="O2" value="60.31" spread="38.333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COGNITIVE PROBLEMS ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.85" spread="20.871"/>
                    <measurement group_id="O2" value="53.24" spread="20.382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COGNITIVE PROBLEMS ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.24" spread="24.367"/>
                    <measurement group_id="O2" value="53.53" spread="26.796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COMMUNICATION ASSESSED BY CHILD - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.15" spread="30.000"/>
                    <measurement group_id="O2" value="63.55" spread="28.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COMMUNICATION ASSESSED BY CHILD - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.31" spread="26.681"/>
                    <measurement group_id="O2" value="57.28" spread="38.948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.68" spread="20.727"/>
                    <measurement group_id="O2" value="67.71" spread="22.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.37" spread="20.811"/>
                    <measurement group_id="O2" value="69.00" spread="23.688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT II ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.41" spread="11.557"/>
                    <measurement group_id="O2" value="85.27" spread="17.325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT II ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.30" spread="12.381"/>
                    <measurement group_id="O2" value="83.80" spread="18.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.16" spread="22.571"/>
                    <measurement group_id="O2" value="79.66" spread="22.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.38" spread="21.012"/>
                    <measurement group_id="O2" value="74.33" spread="26.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT ANXIETY ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.44" spread="30.804"/>
                    <measurement group_id="O2" value="56.27" spread="33.997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TREATMENT ANXIETY ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.03" spread="29.567"/>
                    <measurement group_id="O2" value="57.77" spread="34.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COGNITIVE PROBLEMS ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.29" spread="29.558"/>
                    <measurement group_id="O2" value="61.60" spread="25.807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COGNITIVE PROBLEMS ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.69" spread="29.560"/>
                    <measurement group_id="O2" value="58.53" spread="33.432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COMMUNICATION ASSESSED BY PARENT - BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.57" spread="27.342"/>
                    <measurement group_id="O2" value="67.33" spread="28.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COMMUNICATION ASSESSED BY PARENT - MONTH 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.20" spread="24.037"/>
                    <measurement group_id="O2" value="66.17" spread="28.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score</title>
        <description>Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.</description>
        <time_frame>from randomization up to 12 months after randomization</time_frame>
        <population>All randomized English speaking participants 6 years and older taking apixaban or warfarin with both baseline and post baseline questionnaire scores. Parent inventory includes only participants age &gt;= 34 weeks old.</population>
        <group_list>
          <group group_id="O1">
            <title>Apixaban</title>
            <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
            <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
          </group>
        </group_list>
        <measure>
          <title>Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score</title>
          <description>Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.&#xD;
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.</description>
          <population>All randomized English speaking participants 6 years and older taking apixaban or warfarin with both baseline and post baseline questionnaire scores. Parent inventory includes only participants age &gt;= 34 weeks old.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BASELINE CHILD REPORTED - 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.35" spread="12.887"/>
                    <measurement group_id="O2" value="26.45" spread="12.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POST BASELINE CHILD REPORTED - 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.81" spread="13.380"/>
                    <measurement group_id="O2" value="22.57" spread="16.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASELINE CHILD REPORTED - 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.50" spread="11.787"/>
                    <measurement group_id="O2" value="25.32" spread="11.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POST BASELINE CHILD REPORTED - 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.52" spread="13.251"/>
                    <measurement group_id="O2" value="18.01" spread="10.408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASELINE PARENT REPORTED - 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.97" spread="20.493"/>
                    <measurement group_id="O2" value="39.02" spread="17.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POST BASELINE PARENT REPORTED - 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.32" spread="17.060"/>
                    <measurement group_id="O2" value="37.94" spread="20.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASELINE PARENT REPORTED - 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.37" spread="18.874"/>
                    <measurement group_id="O2" value="39.36" spread="16.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POST BASELINE PARENT REPORTED - 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.10" spread="16.021"/>
                    <measurement group_id="O2" value="33.61" spread="17.943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs are collected from the first dose date until the last dose date + 2 days/ SAEs are collected from the first dose date until the last dose date + 30 days (Up to approximately 13 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 57 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Apixaban</title>
          <description>Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants weighing between &gt;/= 3 and &lt; 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.&#xD;
Children randomized to the apixaban arm of the study weighing &gt;/= 35 kg will be administered apixaban 5 mg twice daily (BID).</description>
        </group>
        <group group_id="E2">
          <title>Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)</title>
          <description>Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.&#xD;
Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</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="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Atrial septal defect acquired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital cystic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoplastic left heart syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Protein-losing gastroenteropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Incorrect dose administered</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Shunt thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Intracardiac pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </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="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Penile haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</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="68" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="62"/>
              </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="8" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email</phone>
      <email>Clinical.Trials@bms.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/NCT02981472
org study id: CV185-362
secondary id: 2016-001247-39
nct id: NCT02981472
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To investigate the safety and pharmacokinetics of apixaban in children with congenital or
      acquired heart disease who have a need for anticoagulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
measure: The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
time frame: From randomization to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)
measure: The Number of Participants With Adjudicated Major Bleeding
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:
fatal bleeding
clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period
bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS
bleeding that requires surgical intervention in an operating suite, including interventional radiology
measure: The Number of Participants With Adjudicated CRNM Bleeding
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:
overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition
bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
measure: The Number of Participants With All Adjudicated Bleeding
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with all adjudicated bleeding events
measure: The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
measure: The Number of Participant Deaths in the Study
time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
description: The number of participant deaths in the study.
measure: Maximum Observed Concentration (Cmax)
time frame: From first dose up to 6 months after first dose
measure: Trough Observed Concentration (Cmin)
time frame: From first dose up to 6 months after first dose
measure: Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
time frame: From first dose up to 6 months after first dose
measure: Time of Maximum Observed Concentration (Tmax)
time frame: From first dose up to 6 months after first dose
measure: Anti-FXa Activity
time frame: From first dose up to 6 months after first dose
description: Anti-FXa Activity was measured to assess participant plasma apixaban levels.
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.
measure: Chromogenic FX Assay (Apparent FX Level)
time frame: From first dose up to 6 months after first dose
description: Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.
measure: The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
time frame: from randomization up to 12 months after randomization
description: Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.
measure: Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
time frame: from randomization up to 12 months after randomization
description: Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.
arm group label: Apixaban
arm group type: Experimental
arm group label: LMWH/VKA
arm group type: Active Comparator
intervention type: Drug
intervention name: Apixaban
description: Specified dose on specified days
arm group label: Apixaban
other name: Eliquis
intervention type: Drug
intervention name: Vitamin K Antagonist (VKA)
description: Specified dose on specified days
arm group label: LMWH/VKA
other name: Warfarin
intervention type: Drug
intervention name: Low Molecular Weight Heparin (LMWH)
description: Specified dose on specified days
arm group label: LMWH/VKA
other name: Enoxaparin
criteria: 
gender: All
minimum age: 28 Days
maximum age: 17 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Austria
country: Brazil
country: Canada
country: Finland
country: Germany
country: Israel
country: Italy
country: Mexico
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
country: France
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Thrombosis
mesh term: Vitamin K
mesh term: Heparin
mesh term: Enoxaparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin
mesh term: Warfarin
mesh term: Apixaban
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 