<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/NCT02234843</url>
  </required_header>
  <id_info>
    <org_study_id>14372</org_study_id>
    <secondary_id>2014-000565-47</secondary_id>
    <nct_id>NCT02234843</nct_id>
  </id_info>
  <brief_title>EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis</brief_title>
  <acronym>EINSTEIN Jr</acronym>
  <official_title>Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism</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 evaluate comparative efficacy and safety of rivaroxaban to&#xD;
      standard of care in children with acute venous thromboembolism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2014</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</measure>
    <time_frame>During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged &lt;2 years for whom it was 1 month)</time_frame>
    <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</measure>
    <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
    <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period</measure>
    <time_frame>During extended treatment period: up to month 12.</time_frame>
    <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. &gt;2 and ≤ 30 Days After Stop of Study Medication)</measure>
    <time_frame>More than 2 and up to 30 days after stop of study medication</time_frame>
    <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period</measure>
    <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
    <description>The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period</measure>
    <time_frame>During extended treatment period: up to month 12.</time_frame>
    <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period</measure>
    <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
    <description>The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-24)ss in Plasma</measure>
    <time_frame>over 24 hours</time_frame>
    <description>AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss in Plasma</measure>
    <time_frame>0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)</time_frame>
    <description>Maximum drug concentration in measured matrix at steady state during a dosage interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough,ss in Plasma</measure>
    <time_frame>0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)</time_frame>
    <description>Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</measure>
    <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</measure>
    <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
    <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
    <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</measure>
    <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
    <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>BAY59-7939</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets</description>
    <arm_group_label>BAY59-7939</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension</description>
    <arm_group_label>BAY59-7939</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.&#xD;
dose : as per standard of care</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged birth to &lt; 18 years with confirmed venous thromboembolism who receive&#xD;
             initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low&#xD;
             molecular weight heparin) or fondaparinux and require anticoagulant therapy for at&#xD;
             least 90 days. However, children aged birth to &lt; 2 years with catheter-related&#xD;
             thrombosis require anticoagulant therapy for at least 30 days.&#xD;
&#xD;
          -  For children younger than 6 months:&#xD;
&#xD;
               -  Gestational age at birth of at least 37 weeks.&#xD;
&#xD;
               -  Oral feeding/nasogastric/gastric feeding for at least 10 days.&#xD;
&#xD;
               -  Body weight ≥2600 g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding or bleeding risk contraindicating anticoagulant therapy&#xD;
&#xD;
          -  An estimated glomerular filtration rate (eGFR) &lt; 30 mL/min/1.73 m*2 (in children&#xD;
             younger than 1 year, serum creatinine results above 97.5th percentile excludes&#xD;
             participation)&#xD;
&#xD;
          -  Hepatic disease which is associated with either: coagulopathy leading to a clinically&#xD;
             relevant bleeding risk, or ALT&gt; 5x upper level of normal (ULN) or total bilirubin &gt; 2x&#xD;
             ULN with direct bilirubin &gt; 20% of the total&#xD;
&#xD;
          -  Platelet count &lt; 50 x 109/L&#xD;
&#xD;
          -  Sustained uncontrolled 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), including but not limited to all human immunodeficiency&#xD;
             virus protease inhibitors and the following azole antimycotics agents: ketoconazole,&#xD;
             itraconazole, voriconazole, posaconazole, if used systemically&#xD;
&#xD;
          -  Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin,&#xD;
             rifabutin, phenobarbital, phenytoin and carbamazepine&#xD;
&#xD;
          -  Childbearing potential without proper contraceptive measures, pregnancy or breast&#xD;
             feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
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    <country>China</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Poland</country>
    <country>Romania</country>
  </removed_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>January 29, 2020</results_first_submitted>
  <results_first_submitted_qc>March 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 1, 2020</results_first_posted>
  <last_update_submitted>March 13, 2020</last_update_submitted>
  <last_update_submitted_qc>March 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02234843/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02234843/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at 109 study centers in 28 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, UK, and USA between 13 Nov 2014 and 30 Jan 2019.</recruitment_details>
      <pre_assignment_details>A total of 520 children were screened for this study. Twenty children did not pass the screen of inclusion/exclusion criteria. A total of 500 children were randomized 2:1 to study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rivaroxaban, Aged 12-&lt;18</title>
          <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
        </group>
        <group group_id="P2">
          <title>Rivaroxaban, Aged 6-&lt;12</title>
          <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="P3">
          <title>Rivaroxaban, Aged 2-&lt;6</title>
          <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="P4">
          <title>Rivaroxaban, Aged 0.5-&lt;2</title>
          <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="P5">
          <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
          <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="P6">
          <title>Comparator, Aged 12-&lt;18</title>
          <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to Vitamin K Antagonist (VKA) therapy. VKA dosages were adjusted to maintain the international normalized ratio (INR) within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="P7">
          <title>Comparator, Aged 6-&lt;12</title>
          <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="P8">
          <title>Comparator, Aged 2-&lt;6</title>
          <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="P9">
          <title>Comparator, Aged 0.5-&lt;2</title>
          <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="P10">
          <title>Comparator, Aged Birth-&lt;0.5</title>
          <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="47"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="16"/>
                <participants group_id="P6" count="92"/>
                <participants group_id="P7" count="34"/>
                <participants group_id="P8" count="22"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="14"/>
                <participants group_id="P6" count="79"/>
                <participants group_id="P7" count="32"/>
                <participants group_id="P8" count="20"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="13"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Efficacy outcome reached</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient convenience</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Recovery</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" 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, Aged 12-&lt;18</title>
          <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
        </group>
        <group group_id="B2">
          <title>Rivaroxaban, Aged 6-&lt;12</title>
          <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="B3">
          <title>Rivaroxaban, Aged 2-&lt;6</title>
          <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="B4">
          <title>Rivaroxaban, Aged 0.5-&lt;2</title>
          <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="B5">
          <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
          <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
        <group group_id="B6">
          <title>Comparator, Aged 12-&lt;18</title>
          <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="B7">
          <title>Comparator, Aged 6-&lt;12</title>
          <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="B8">
          <title>Comparator, Aged 2-&lt;6</title>
          <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="B9">
          <title>Comparator, Aged 0.5-&lt;2</title>
          <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="B10">
          <title>Comparator, Aged Birth-&lt;0.5</title>
          <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
        </group>
        <group group_id="B11">
          <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="184"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="47"/>
            <count group_id="B4" value="21"/>
            <count group_id="B5" value="16"/>
            <count group_id="B6" value="92"/>
            <count group_id="B7" value="34"/>
            <count group_id="B8" value="22"/>
            <count group_id="B9" value="9"/>
            <count group_id="B10" value="8"/>
            <count group_id="B11" value="500"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>12-&lt;18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="92"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6-&lt;12 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="34"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2-&lt;6 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="22"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>0.5-&lt;2 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Birth-&lt;0.5 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="24"/>
                  </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="97"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="55"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="37"/>
                    <measurement group_id="B7" value="19"/>
                    <measurement group_id="B8" value="13"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="79"/>
                    <measurement group_id="B7" value="26"/>
                    <measurement group_id="B8" value="19"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="429"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</title>
        <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
        <time_frame>During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged &lt;2 years for whom it was 1 month)</time_frame>
        <population>Full analysis set (FAS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban Group</title>
            <description>Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Group</title>
            <description>Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</title>
          <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
          <population>Full analysis set (FAS)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
                <count group_id="O2" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.4" upper_limit="3.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1509</p_value>
            <method>Expl. Cox Proportional Hazards Model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</title>
        <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
        <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
        <population>Full analysis set (FAS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O7">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period</title>
          <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
          <population>Full analysis set (FAS)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.7" lower_limit="0.7" upper_limit="5.3"/>
                    <measurement group_id="O2" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="5.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O4" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="8.3"/>
                    <measurement group_id="O5" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="14.6"/>
                    <measurement group_id="O6" value="3.3" spread="0.9" lower_limit="0.9" upper_limit="8.6"/>
                    <measurement group_id="O7" value="2.9" spread="0.2" lower_limit="0.2" upper_limit="15.1"/>
                    <measurement group_id="O8" value="4.5" spread="0.2" lower_limit="0.2" upper_limit="20.7"/>
                    <measurement group_id="O9" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="18.4"/>
                    <measurement group_id="O10" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period</title>
        <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.</description>
        <time_frame>During extended treatment period: up to month 12.</time_frame>
        <population>Full analysis set (FAS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O7">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period</title>
          <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.</description>
          <population>Full analysis set (FAS)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="1"/>
                <count group_id="O10" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extension 1 (month 3 to 6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="1"/>
                    <count group_id="O10" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0.1" upper_limit="10.9"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="14.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="16.3"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="14.6"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="37.7"/>
                    <measurement group_id="O9" value="0.0" lower_limit="0.0" upper_limit="95.0"/>
                    <measurement group_id="O10" value="0.0" lower_limit="0.0" upper_limit="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extension 2 (month 6 to 9)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="3"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.1" upper_limit="13.4"/>
                    <measurement group_id="O2" value="5.3" lower_limit="0.3" upper_limit="24.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="29.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="40.2"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="63.2"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extension 3 (month 9 to 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="63.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="95.2"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. &gt;2 and ≤ 30 Days After Stop of Study Medication)</title>
        <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.</description>
        <time_frame>More than 2 and up to 30 days after stop of study medication</time_frame>
        <population>Full analysis set (FAS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O7">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. &gt;2 and ≤ 30 Days After Stop of Study Medication)</title>
          <description>The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.</description>
          <population>Full analysis set (FAS)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period</title>
        <description>The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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).</description>
        <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
        <population>Safety analysis set (SAF)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban Group</title>
            <description>Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Group</title>
            <description>Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period</title>
          <description>The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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).</description>
          <population>Safety analysis set (SAF)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.6" upper_limit="5.5"/>
                    <measurement group_id="O2" value="1.9" lower_limit="0.5" upper_limit="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period</title>
        <description>The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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).</description>
        <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
        <population>Safety analysis set (SAF)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O7">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period</title>
          <description>The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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).</description>
          <population>Safety analysis set (SAF)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="89"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.5" lower_limit="0.5" upper_limit="4.7"/>
                    <measurement group_id="O2" value="3.0" spread="0.5" lower_limit="0.5" upper_limit="9.6"/>
                    <measurement group_id="O3" value="6.5" spread="1.8" lower_limit="1.8" upper_limit="17.7"/>
                    <measurement group_id="O4" value="4.8" spread="0.2" lower_limit="0.2" upper_limit="21.8"/>
                    <measurement group_id="O5" value="6.7" spread="0.3" lower_limit="0.3" upper_limit="30.2"/>
                    <measurement group_id="O6" value="2.2" spread="0.4" lower_limit="0.4" upper_limit="7.3"/>
                    <measurement group_id="O7" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="9.0"/>
                    <measurement group_id="O8" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="13.9"/>
                    <measurement group_id="O9" value="11.1" spread="0.6" lower_limit="0.6" upper_limit="44.3"/>
                    <measurement group_id="O10" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period</title>
        <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.</description>
        <time_frame>During extended treatment period: up to month 12.</time_frame>
        <population>Safety analysis set (SAF)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O4">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O7">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period</title>
          <description>Incidence rates for all children except those aged &lt; 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.</description>
          <population>Safety analysis set (SAF)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="8"/>
                <count group_id="O9" value="7"/>
                <count group_id="O10" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extension 1 (month 3 to 6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="19"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="8"/>
                    <count group_id="O9" value="7"/>
                    <count group_id="O10" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.1" upper_limit="5.3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="6.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="95.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="14.6"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="16.3"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="34.9"/>
                    <measurement group_id="O9" value="0.0" lower_limit="0.0" upper_limit="37.7"/>
                    <measurement group_id="O10" value="0.0" lower_limit="0.0" upper_limit="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extension 2 (month 6 to 9)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.1" upper_limit="13.4"/>
                    <measurement group_id="O3" value="5.3" lower_limit="0.3" upper_limit="24.4"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="29.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="40.2"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="63.2"/>
                    <measurement group_id="O9" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extension 3 (month 9 to 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="23.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="63.2"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="95.0"/>
                    <measurement group_id="O9" value="0.0" lower_limit="0.0" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period</title>
        <description>The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
        <time_frame>During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged &lt;2 years for whom it was 1 month)</time_frame>
        <population>Full analysis set (FAS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O6">
            <title>Comparator, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O7">
            <title>Comparator, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O8">
            <title>Comparator, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O9">
            <title>Comparator, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
          <group group_id="O10">
            <title>Comparator, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period</title>
          <description>The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population</description>
          <population>Full analysis set (FAS)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.7" lower_limit="0.7" upper_limit="5.3"/>
                    <measurement group_id="O2" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="5.3"/>
                    <measurement group_id="O3" value="2.1" spread="0.1" lower_limit="0.1" upper_limit="10.7"/>
                    <measurement group_id="O4" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="14.6"/>
                    <measurement group_id="O5" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="19.8"/>
                    <measurement group_id="O6" value="4.3" spread="1.5" lower_limit="1.5" upper_limit="10.3"/>
                    <measurement group_id="O7" value="2.9" spread="0.2" lower_limit="0.2" upper_limit="15.1"/>
                    <measurement group_id="O8" value="4.5" spread="0.2" lower_limit="0.2" upper_limit="20.7"/>
                    <measurement group_id="O9" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="29.9"/>
                    <measurement group_id="O10" value="0.0" spread="0.0" lower_limit="0.0" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-24)ss in Plasma</title>
        <description>AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.</description>
        <time_frame>over 24 hours</time_frame>
        <population>Pharmacokinetics analysis set (PKS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-24)ss in Plasma</title>
          <description>AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.</description>
          <population>Pharmacokinetics analysis set (PKS)</population>
          <units>microgram*hour per liter</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="173"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2120" spread="26.4" lower_limit="26.4"/>
                    <measurement group_id="O2" value="1960" spread="31.7" lower_limit="31.7"/>
                    <measurement group_id="O3" value="2380" spread="40.7" lower_limit="40.7"/>
                    <measurement group_id="O4" value="1840" spread="36.4" lower_limit="36.4"/>
                    <measurement group_id="O5" value="1590" spread="29.6" lower_limit="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax,ss in Plasma</title>
        <description>Maximum drug concentration in measured matrix at steady state during a dosage interval</description>
        <time_frame>0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)</time_frame>
        <population>Pharmacokinetics analysis set (PKS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax,ss in Plasma</title>
          <description>Maximum drug concentration in measured matrix at steady state during a dosage interval</description>
          <population>Pharmacokinetics analysis set (PKS)</population>
          <units>microgram per liter</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="173"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237" spread="20.6" lower_limit="20.6"/>
                    <measurement group_id="O2" value="184" spread="36.2" lower_limit="36.2"/>
                    <measurement group_id="O3" value="182" spread="31.2" lower_limit="31.2"/>
                    <measurement group_id="O4" value="136" spread="29.4" lower_limit="29.4"/>
                    <measurement group_id="O5" value="119" spread="24.1" lower_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough,ss in Plasma</title>
        <description>Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state</description>
        <time_frame>0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)</time_frame>
        <population>Pharmacokinetics analysis set (PKS)</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O3">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O4">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
          <group group_id="O5">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough,ss in Plasma</title>
          <description>Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state</description>
          <population>Pharmacokinetics analysis set (PKS)</population>
          <units>microgram per liter</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="173"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="45.8" lower_limit="45.8"/>
                    <measurement group_id="O2" value="21.4" spread="62.7" lower_limit="62.7"/>
                    <measurement group_id="O3" value="31.6" spread="70.1" lower_limit="70.1"/>
                    <measurement group_id="O4" value="22.9" spread="68.6" lower_limit="68.6"/>
                    <measurement group_id="O5" value="18.5" spread="50.4" lower_limit="50.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.26" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.41" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="1.09" lower_limit="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.12" lower_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratios</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
        <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
          <description>Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=154</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=149</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=153</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.39" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.23" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="0.83" lower_limit="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="0.06" lower_limit="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
        <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
        <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
          <description>The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
        <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 12-&lt;18</title>
            <description>Children aged 12-&lt;18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-&lt;18 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=141</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.46" spread="124.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=164</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="254.66" spread="188.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=167</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="255.40" spread="171.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (20-24h) n=58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.12" spread="175.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
        <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206.89" spread="105.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="263.24" spread="156.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243.45" spread="124.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (20-24h) n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.39" spread="14.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
        <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 6-&lt;12</title>
            <description>Children aged 6-&lt;12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-&lt;12 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.82" spread="76.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.10" spread="102.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.53" spread="81.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (10-16h) n=20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.49" spread="66.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
        <time_frame>Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (2.5-4h) n=37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177.78" spread="147.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.03" spread="95.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (10-16h) n=18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.40" spread="51.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-1.5h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247.54" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2.5-4h) n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160.71" spread="153.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-8h) n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.09" spread="81.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 2-&lt;6</title>
            <description>Children aged 2-&lt;6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-&lt;6 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209.67" spread="127.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.46" spread="78.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (10-16h) n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.56" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
        <time_frame>Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged 0.5-&lt;2</title>
            <description>Children aged 0.5-&lt;2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-&lt;2 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.35" spread="97.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 (2-6h) n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.24" spread="125.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 (10-16h) n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.40" spread="4.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.30" spread="NA">'NA' denotes data that cannot be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
        <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
        <time_frame>Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60</time_frame>
        <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban, Aged Birth-&lt;0.5</title>
            <description>Children aged birth-&lt;0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-&lt;0.5 Years</title>
          <description>This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.</description>
          <population>Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 30 (0.5-3h) n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.12" spread="82.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 (2-6h) n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.03" spread="181.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After randomization until last intake of study medication plus 2 days, up to 1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comparator Group</title>
          <description>Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart</description>
        </group>
        <group group_id="E2">
          <title>Rivaroxaban Group</title>
          <description>Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of &lt; 20 kg received rivaroxaban as oral suspension.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="78" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sickle cell anaemia with crisis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Low cardiac output syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Postural orthostatic tachycardia syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular dystrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </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="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Intestinal dilatation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eczema herpeticum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pyoderma streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tonsillitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Post lumbar puncture syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Accidental underdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Incorrect route of product administration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Drug clearance decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stoma output decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Craniopharyngioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Myxofibrosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sciatic nerve neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Encephalitis autoimmune</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hemianaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hemiparaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>IgA nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urinary bladder haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </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="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemorrhagic ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diaphragmatic paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pulmonary vein stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Laryngeal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Colostomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mastoidectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sclerotherapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lumboperitoneal shunt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Faecal disimpaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="121" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="275" subjects_at_risk="329"/>
              </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="5" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="20" subjects_affected="11" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Autoimmune neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemorrhagic diathesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Immunodeficiency congenital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Protein S deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Conductive deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amblyopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Astigmatism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Heterophoria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ocular hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Optic disc haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="162"/>
                <counts group_id="E2" events="27" subjects_affected="17" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="162"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="162"/>
                <counts group_id="E2" events="30" subjects_affected="25" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="162"/>
                <counts group_id="E2" events="25" subjects_affected="22" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tongue blistering</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tongue coated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tongue geographic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="162"/>
                <counts group_id="E2" events="42" subjects_affected="36" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Perianal erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Appendix disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tooth socket haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="162"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site extravasation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="14" subjects_at_risk="162"/>
                <counts group_id="E2" events="51" subjects_affected="37" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Application site vesicles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Catheter site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Application site hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vaccination site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Medical device site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gallbladder disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Secondary immunodeficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Acute graft versus host disease in skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eyelid infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Giardiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Injection site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="162"/>
                <counts group_id="E2" events="36" subjects_affected="29" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Scarlet fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cardiac infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mastoid abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ear infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Greenstick fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="21" subjects_affected="14" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Wound secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Exposure to communicable disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="162"/>
                <counts group_id="E2" events="19" subjects_affected="15" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Postoperative thoracic procedure complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Underdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stoma site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Incision site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anaphylactic transfusion reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eye contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stoma site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stoma site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Accidental underdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vascular access site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cerebral radiation injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nasal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Product prescribing error</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="162"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Aspiration bone marrow</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bilirubin conjugated increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Biopsy liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood bilirubin unconjugated increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Coagulation factor VIII level increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Fibrin D dimer increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Full blood count abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>International normalised ratio abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lumbar puncture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nuclear magnetic resonance imaging</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="20" subjects_affected="9" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphocyte percentage decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lipoprotein (a) increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bacterial test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anticoagulation drug level above therapeutic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anticoagulation drug level below therapeutic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Angiogram</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Clostridium test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Staphylococcus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Chlamydia test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Influenza A virus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Human rhinovirus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Folate deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperchloraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Selenium deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperhomocysteinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="329"/>
              </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="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="162"/>
                <counts group_id="E2" events="25" subjects_affected="23" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Craniopharyngioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ewing's sarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lymphangioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Clumsiness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dizziness exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="28" subjects_affected="24" subjects_at_risk="162"/>
                <counts group_id="E2" events="75" subjects_affected="56" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>VIth nerve disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Toxic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Choroid fissure cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Attention deficit/hyperactivity disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Emotional disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Somnambulism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Phonophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Post stroke depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypercalciuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Renal atrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urinary bladder haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urethral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="11" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Menometrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="29" subjects_affected="21" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Polycystic ovaries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Priapism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="10" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Genital tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Perineal erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="162"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="32" subjects_affected="20" subjects_at_risk="162"/>
                <counts group_id="E2" events="62" subjects_affected="40" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pleural adhesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pulmonary infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mediastinal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oropharyngeal plaque</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pulmonary pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Respiratory symptom</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Alopecia areata</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Blood blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hirsutism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Livedo reticularis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash follicular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin striae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stasis dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Umbilical haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Bladder catheterisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Intra-uterine contraceptive device insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ventricular drainage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Gastrointestinal tube insertion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Central venous catheterisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hepatitis B immunisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Oophorectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Mastoid operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Stem cell transplant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Central venous catheter removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Endotracheal intubation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Ventriculo-cardiac shunt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Laryngeal mask airway insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Post thrombotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>Superficial vein prominence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </event>
              <event>
                <sub_title>May-Thurner syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="329"/>
              </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 less than or equal to 60 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>Therapeutic Area Head</organization>
      <phone>(+) 1-888-8422937</phone>
      <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/NCT02234843
org study id: 14372
secondary id: 2014-000565-47
nct id: NCT02234843
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to
      standard of care in children with acute venous thromboembolism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
time frame: During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)
description: The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
measure: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
time frame: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
description: The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
measure: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period
time frame: During extended treatment period: up to month 12.
description: Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.
measure: Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)
time frame: More than 2 and up to 30 days after stop of study medication
description: The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.
measure: Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period
time frame: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
description: The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding 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 (temporary) cessation 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: Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period
time frame: During extended treatment period: up to month 12.
description: Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.
measure: Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period
time frame: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
description: The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
measure: AUC(0-24)ss in Plasma
time frame: over 24 hours
description: AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.
measure: Cmax,ss in Plasma
time frame: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)
description: Maximum drug concentration in measured matrix at steady state during a dosage interval
measure: Ctrough,ss in Plasma
time frame: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)
description: Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
time frame: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
time frame: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
description: Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
time frame: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
description: The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
measure: Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
time frame: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
measure: Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
measure: Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
time frame: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
measure: Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
measure: Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
measure: Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
time frame: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
measure: Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
time frame: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
measure: Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
time frame: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
description: This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
arm group label: BAY59-7939
arm group type: Experimental
description: Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.
arm group label: Standard of Care
arm group type: Experimental
description: Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets
arm group label: BAY59-7939
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension
arm group label: BAY59-7939
intervention type: Drug
intervention name: Standard of Care
description: LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.
dose : as per standard of care
arm group label: Standard of Care
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: China
country: Finland
country: France
country: Germany
country: Hong Kong
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Japan
country: Mexico
country: Netherlands
country: Portugal
country: Russian Federation
country: Singapore
country: Slovakia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: United States
country: Bulgaria
country: Poland
country: Romania
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Rivaroxaban
provided document: 
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certain agreements: 
point of contact: 