<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/NCT01684423</url>
  </required_header>
  <id_info>
    <org_study_id>14373</org_study_id>
    <secondary_id>2011-004539-30</secondary_id>
    <nct_id>NCT01684423</nct_id>
  </id_info>
  <brief_title>Oral Rivaroxaban in Children With Venous Thrombosis</brief_title>
  <acronym>EINSTEINJunior</acronym>
  <official_title>30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</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>
      The purpose of this study is to find out whether rivaroxaban is safe to use in children and&#xD;
      how long it stays in the body. There will also be a check for bleeding and worsening of blood&#xD;
      clots.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2013</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 1, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events</measure>
    <time_frame>From start of study drug administration until end of the 30-day treatment period</time_frame>
    <description>Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:&#xD;
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or&#xD;
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or&#xD;
occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or&#xD;
contributing to death.&#xD;
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:&#xD;
medical intervention, or&#xD;
unscheduled contact (visit or telephone call) with a physician, or&#xD;
cessation (temporary) of study treatment, or&#xD;
discomfort for the child such as pain or&#xD;
impairment of activities of daily life (such as loss of school days or hospitalization).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Symptomatic Recurrent Venous Thromboembolism</measure>
    <time_frame>From start of study drug administration until end of the 30-day treatment period</time_frame>
    <description>The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden</measure>
    <time_frame>Repeat imaging at the end of the 30 day treatment period</time_frame>
    <description>The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Prothrombin Time at Specified Time Points</measure>
    <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
    <description>Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points</measure>
    <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
    <description>The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-factor Xa Values at Specified Time Points</measure>
    <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
    <description>The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points</measure>
    <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
    <description>Geometric and percentage geometric coefficient of variation (%CV) were reported.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Venous Thrombosis</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - &lt;18</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator, Age: 12 - &lt;18 years</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - &lt;12 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - &lt;12 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator, Age: 6 - &lt;12 years</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects aged from 6 - &lt;12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
    <arm_group_label>Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - &lt;18</arm_group_label>
    <arm_group_label>Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - &lt;12 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active comparator</intervention_name>
    <description>Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).</description>
    <arm_group_label>Comparator, Age: 12 - &lt;18 years</arm_group_label>
    <arm_group_label>Comparator, Age: 6 - &lt;12 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (BAY59-7939) suspension</intervention_name>
    <description>Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.</description>
    <arm_group_label>Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - &lt;12 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6 to &lt; 18 years with documented symptomatic or asymptomatic venous&#xD;
             thrombosis treated for at least 2 months or, in case of catheter related thrombosis,&#xD;
             treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux&#xD;
             and/or VKA (vitamin K antagonist).&#xD;
&#xD;
          -  Informed consent provided and, if applicable, child assent provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding or high risk for bleeding contraindicating anticoagulant therapy&#xD;
&#xD;
          -  Symptomatic progression of venous thrombosis during preceding anticoagulant treatment&#xD;
&#xD;
          -  Planned invasive procedures, including lumbar puncture and removal of non peripherally&#xD;
             placed central lines during study treatment&#xD;
&#xD;
          -  An estimated glomerular filtration rate (eGFR) &lt; 30 mL/min/1.73 m2&#xD;
&#xD;
          -  Hepatic disease which is associated with coagulopathy leading to a clinically relevant&#xD;
             bleeding risk or ALT &gt; 5x upper level of normal (ULN) or total bilirubin &gt; 2x ULN with&#xD;
             direct bilirubin &gt; 20% of the total&#xD;
&#xD;
          -  Platelet count &lt; 50 x 10^9/L&#xD;
&#xD;
          -  Hypertension defined as &gt; 95th age percentile&#xD;
&#xD;
          -  Life expectancy &lt; 3 months&#xD;
&#xD;
          -  Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)&#xD;
             and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors&#xD;
             and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole,&#xD;
             posaconazole, if used systemically&#xD;
&#xD;
          -  Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin,&#xD;
             phenobarbital, phenytoin and carbamazepine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027-6089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3974</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-2196</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-2602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205-2696</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Brisbane</city>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>BORDEAUX cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier Cedex</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>NANTES Cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rennes Cedex</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>TOULOUSE Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Freiburg</city>
        <state>Baden-Württemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beer Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Petach Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ramat Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bari</city>
        <state>Puglia</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Basel</city>
        <state>Basel-Stadt</state>
        <zip>4056</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Gallen</city>
        <state>Sankt Gallen</state>
        <zip>9006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>August 25, 2017</results_first_submitted>
  <results_first_submitted_qc>August 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2017</results_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</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>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at multiple centers in 10 countries worldwide between 19 February 2013 (first subject first visit) and 01 September 2016 (last subject last visit).</recruitment_details>
      <pre_assignment_details>A total of 68 subjects were screened, of these 4 subjects failed screening. The remaining 64 subjects were randomized, of whom 63 subjects were treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
        </group>
        <group group_id="P2">
          <title>Comparator, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
        </group>
        <group group_id="P3">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
        </group>
        <group group_id="P4">
          <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
        </group>
        <group group_id="P5">
          <title>Comparator, Age: 6 - &lt; 12 Years</title>
          <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
        </group>
        <group group_id="B2">
          <title>Comparator, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
        </group>
        <group group_id="B4">
          <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
        </group>
        <group group_id="B5">
          <title>Comparator, Age: 6 - &lt; 12 Years</title>
          <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
        </group>
        <group group_id="B6">
          <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="11"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="19"/>
            <count group_id="B5" value="7"/>
            <count group_id="B6" value="63"/>
          </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="15.5" spread="1.2"/>
                    <measurement group_id="B2" value="14.8" spread="1.0"/>
                    <measurement group_id="B3" value="8.5" spread="2.1"/>
                    <measurement group_id="B4" value="8.3" spread="1.9"/>
                    <measurement group_id="B5" value="9.0" spread="2.0"/>
                    <measurement group_id="B6" value="11.0" spread="3.7"/>
                  </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="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events</title>
        <description>Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:&#xD;
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or&#xD;
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or&#xD;
occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or&#xD;
contributing to death.&#xD;
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:&#xD;
medical intervention, or&#xD;
unscheduled contact (visit or telephone call) with a physician, or&#xD;
cessation (temporary) of study treatment, or&#xD;
discomfort for the child such as pain or&#xD;
impairment of activities of daily life (such as loss of school days or hospitalization).</description>
        <time_frame>From start of study drug administration until end of the 30-day treatment period</time_frame>
        <population>Full analysis set. Data was evaluated only for subjects who received active study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Comparator, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
          <group group_id="O5">
            <title>Comparator, Age: 6 - &lt; 12 Years</title>
            <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events</title>
          <description>Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:&#xD;
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or&#xD;
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or&#xD;
occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or&#xD;
contributing to death.&#xD;
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:&#xD;
medical intervention, or&#xD;
unscheduled contact (visit or telephone call) with a physician, or&#xD;
cessation (temporary) of study treatment, or&#xD;
discomfort for the child such as pain or&#xD;
impairment of activities of daily life (such as loss of school days or hospitalization).</description>
          <population>Full analysis set. Data was evaluated only for subjects who received active study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Major bleeding events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinically relevant non-major bleeding events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Symptomatic Recurrent Venous Thromboembolism</title>
        <description>The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.</description>
        <time_frame>From start of study drug administration until end of the 30-day treatment period</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Comparator, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
          <group group_id="O5">
            <title>Comparator, Age: 6 - &lt; 12 Years</title>
            <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Symptomatic Recurrent Venous Thromboembolism</title>
          <description>The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.</description>
          <population>Full analysis set</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="7"/>
              </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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden</title>
        <description>The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.</description>
        <time_frame>Repeat imaging at the end of the 30 day treatment period</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Comparator, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
          <group group_id="O5">
            <title>Comparator, Age: 6 - &lt; 12 Years</title>
            <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden</title>
          <description>The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.</description>
          <population>Full analysis set</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No relevant change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Prothrombin Time at Specified Time Points</title>
        <description>Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.</description>
        <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
        <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Prothrombin Time at Specified Time Points</title>
          <description>Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.</description>
          <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: 2 to 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.964" spread="3.822"/>
                    <measurement group_id="O2" value="9.083" spread="2.513"/>
                    <measurement group_id="O3" value="3.147" spread="2.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 6 to 8 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.218" spread="2.977"/>
                    <measurement group_id="O2" value="2.817" spread="1.628"/>
                    <measurement group_id="O3" value="1.984" spread="1.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 10 to 16 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O3" value="0.156" spread="1.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 20 to 24 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.082" spread="1.020"/>
                    <measurement group_id="O2" value="-0.327" spread="1.332"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points</title>
        <description>The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.</description>
        <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
        <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points</title>
          <description>The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.</description>
          <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: 2 to 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.982" spread="4.470"/>
                    <measurement group_id="O2" value="12.818" spread="5.210"/>
                    <measurement group_id="O3" value="2.995" spread="5.616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 6 to 8 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.136" spread="2.641"/>
                    <measurement group_id="O2" value="5.900" spread="4.942"/>
                    <measurement group_id="O3" value="1.858" spread="4.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 10 to 16 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O3" value="-0.483" spread="6.488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 20 to 24 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.345" spread="3.190"/>
                    <measurement group_id="O2" value="1.240" spread="4.992"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-factor Xa Values at Specified Time Points</title>
        <description>The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.</description>
        <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
        <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-factor Xa Values at Specified Time Points</title>
          <description>The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.</description>
          <population>Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.</population>
          <units>microgram per liter (mcg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.081" spread="6.136"/>
                    <measurement group_id="O2" value="8.136" spread="3.069"/>
                    <measurement group_id="O3" value="31.553" spread="25.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 2 to 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185.481" spread="53.326"/>
                    <measurement group_id="O2" value="252.853" spread="71.072"/>
                    <measurement group_id="O3" value="99.415" spread="54.415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 6 to 8 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.223" spread="54.339"/>
                    <measurement group_id="O2" value="68.670" spread="32.845"/>
                    <measurement group_id="O3" value="77.929" spread="50.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 10 to 16 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O3" value="30.927" spread="18.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 20 to 24 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.038" spread="7.653"/>
                    <measurement group_id="O2" value="8.409" spread="3.664"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points</title>
        <description>Geometric and percentage geometric coefficient of variation (%CV) were reported.</description>
        <time_frame>0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31</time_frame>
        <population>Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
            <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
            <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points</title>
          <description>Geometric and percentage geometric coefficient of variation (%CV) were reported.</description>
          <population>Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.</population>
          <units>microgram per liter (mcg/L)</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="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4822" spread="40.6726"/>
                    <measurement group_id="O2" value="7.4367" spread="152.9768"/>
                    <measurement group_id="O3" value="41.6025" spread="183.6873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 2 to 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219.6933" spread="35.7518"/>
                    <measurement group_id="O2" value="240.6319" spread="18.3387"/>
                    <measurement group_id="O3" value="119.2201" spread="52.9889"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: 6 to 8 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.6723" spread="49.1882"/>
                    <measurement group_id="O2" value="96.8051" spread="41.8155"/>
                    <measurement group_id="O3" value="100.5992" spread="52.6497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 10 to 16 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                    <measurement group_id="O3" value="43.5223" spread="81.7283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31: 20 to 24 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3252" spread="43.1274"/>
                    <measurement group_id="O2" value="9.4654" spread="167.7545"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data is not available because no subjects were evaluated for the given time points.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration until 30 day post study treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.</description>
        </group>
        <group group_id="E2">
          <title>Comparator, Age: 12 - &lt;18 Years</title>
          <description>Subjects aged from 12 - &lt;18 years received comparator as per standard of care.</description>
        </group>
        <group group_id="E3">
          <title>Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.</description>
        </group>
        <group group_id="E4">
          <title>Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - &lt;12 Years</title>
          <description>Subjects aged from 6 - &lt;12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.</description>
        </group>
        <group group_id="E5">
          <title>Comparator, Age: 6 - &lt; 12 Years</title>
          <description>Subjects aged from 6 - &lt; 12 years received comparator as per standard of care.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothalamo-pituitary disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-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="9" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vessel puncture site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vocal cord paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Post thrombotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>BAYER</organization>
      <email>clinical-trials-contact@bayer.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/NCT01684423
org study id: 14373
secondary id: 2011-004539-30
nct id: NCT01684423
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to find out whether rivaroxaban is safe to use in children and
      how long it stays in the body. There will also be a check for bleeding and worsening of blood
      clots.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
time frame: From start of study drug administration until end of the 30-day treatment period
description: Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or
occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or
contributing to death.
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:
medical intervention, or
unscheduled contact (visit or telephone call) with a physician, or
cessation (temporary) of study treatment, or
discomfort for the child such as pain or
impairment of activities of daily life (such as loss of school days or hospitalization).
measure: Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
time frame: From start of study drug administration until end of the 30-day treatment period
description: The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.
measure: Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
time frame: Repeat imaging at the end of the 30 day treatment period
description: The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.
measure: Change From Baseline in Prothrombin Time at Specified Time Points
time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
description: Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
measure: Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
description: The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.
measure: Anti-factor Xa Values at Specified Time Points
time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
description: The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
measure: Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
description: Geometric and percentage geometric coefficient of variation (%CV) were reported.
arm group label: Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18
arm group type: Experimental
description: Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
arm group label: Comparator, Age: 12 - <18 years
arm group type: Active Comparator
description: Subjects aged from 12 - <18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
arm group label: Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years
arm group type: Experimental
description: Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
arm group label: Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years
arm group type: Experimental
description: Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
arm group label: Comparator, Age: 6 - <12 years
arm group type: Active Comparator
description: Subjects aged from 6 - <12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist).
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
arm group label: Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18
arm group label: Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years
intervention type: Drug
intervention name: Active comparator
description: Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
arm group label: Comparator, Age: 12 - <18 years
arm group label: Comparator, Age: 6 - <12 years
intervention type: Drug
intervention name: Rivaroxaban (BAY59-7939) suspension
description: Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
arm group label: Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Australia
country: Austria
country: Canada
country: France
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Switzerland
country: United States
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Rivaroxaban
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 