<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/NCT02202434</url>
  </required_header>
  <id_info>
    <org_study_id>S2282</org_study_id>
    <nct_id>NCT02202434</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement</brief_title>
  <acronym>REPRISE III</acronym>
  <official_title>REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve&#xD;
      System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in&#xD;
      symptomatic subjects with calcific, severe native aortic stenosis who are considered at&#xD;
      extreme or high risk for surgical valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    RCT/Roll-in completed. CAS/21mm/Nested Registry terminated (investigational device is no longer&#xD;
    available)&#xD;
  </why_stopped>
  <start_date type="Actual">September 22, 2014</start_date>
  <completion_date type="Actual">May 21, 2021</completion_date>
  <primary_completion_date type="Actual">March 8, 2017</primary_completion_date>
  <phase>N/A</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>Percentage of Participants With Events Included in the Primary Safety Endpoint</measure>
    <time_frame>30 days following procedure</time_frame>
    <description>Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Events Included in the Primary Effectiveness Endpoint</measure>
    <time_frame>1 year following procedure</time_frame>
    <description>Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation</measure>
    <time_frame>1 year following procedure</time_frame>
    <description>Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Successful Deployment of the Study Valve</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>Successful deployment of the study valve</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>Successful retrieval of the study valve if retrieval is attempted</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>Successful repositioning of the study valve if repositioning is attempted</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Clinical Procedural Success</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Procedural Success</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] &gt;0.9 cm2 for body surface area (BSA) &lt;1.6 m2 and EOA &gt;1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient &lt;20 mm Hg or a peak velocity &lt;3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Assessed by an independent core laboratory - mean and peak aortic gradients</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Assessed by an independent core laboratory - peak aortic velocity</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Status as Evaluated by Quality of Life Questionnaires</measure>
    <time_frame>Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported</time_frame>
    <description>SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year&#xD;
SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.&#xD;
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Mortality</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>All-cause, Cardiovascular, and Non-cardiovascular</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Stroke</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Disabling Stroke and Non-disabling Stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Myocardial Infarction (MI)</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Periprocedural (≤72 hours post index procedure) and spontaneous (&gt;72 hours post index procedure)</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Bleeding</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Life-threatening (or disabling) and major (defined below)&#xD;
Life-threatening or Disabling Bleeding&#xD;
Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)&#xD;
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)&#xD;
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)&#xD;
Major Bleeding (BARC type 3a)&#xD;
Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Acute Kidney Injury</measure>
    <time_frame>≤7 days post index procedure</time_frame>
    <description>Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2&#xD;
Change in serum creatinine (up to 7 days) compared to baseline:&#xD;
Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)&#xD;
Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)&#xD;
Stage 3: Increase in serum creatinine to ≥300% (&gt;3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)&#xD;
-OR-&#xD;
Based on urine output (up to 7 days):&#xD;
Stage 1: &lt;0.5 ml/kg per hour for &gt;6 but &lt;12 hours&#xD;
Stage 2: &lt;0.5 ml/kg per hour for &gt;12 but &lt;24 hours&#xD;
Stage 3: &lt;0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours&#xD;
Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Major Vascular Complication</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Major vascular complication - including access site related and non access site related</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Repeat Procedure for Valve-related Dysfunction</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Repeat procedure for valve-related dysfunction (surgical or interventional therapy)</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With New Permanent Pacemaker Implantation</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>New permanent pacemaker implantation resulting from new or worsened conduction disturbances</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>New onset of atrial fibrillation or atrial flutter</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Coronary Obstruction</measure>
    <time_frame>≤72 hours post index procedure</time_frame>
    <description>Coronary obstruction</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Ventricular Septal Perforation</measure>
    <time_frame>≤72 hours post index procedure</time_frame>
    <description>Ventricular septal perforation</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Mitral Apparatus Damage</measure>
    <time_frame>≤72 hours post index procedure</time_frame>
    <description>Mitral apparatus damage</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Cardiac Tamponade</measure>
    <time_frame>≤72 hours post index procedure</time_frame>
    <description>Cardiac tamponade</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Prosthetic Aortic Valve Malpositioning</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Prosthetic Aortic Valve Thrombosis</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Prosthetic aortic valve thrombosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Prosthetic Aortic Valve Endocarditis</measure>
    <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
    <description>Prosthetic aortic valve endocarditis</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">1425</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Lotus Valve System - Randomized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CoreValve TAVR System - Randomized</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lotus Valve Sytem - Single-arm 21mm Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lotus Valve System - Single-arm Continued Access Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lotus Valve System - Single-arm Roll-in Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LOTUS Edge Valve System - Single-arm Edge Nested Registry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with 23mm, 25mm and 27mm LOTUS Edge Valve System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotus Valve System</intervention_name>
    <description>Procedure: Transcatheter aortic valve replacement (TAVR)</description>
    <arm_group_label>Lotus Valve System - Randomized</arm_group_label>
    <arm_group_label>Lotus Valve System - Single-arm Continued Access Cohort</arm_group_label>
    <arm_group_label>Lotus Valve System - Single-arm Roll-in Cohort</arm_group_label>
    <arm_group_label>Lotus Valve Sytem - Single-arm 21mm Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoreValve/Evolut R Transcatheter Aortic Valve Replacement System</intervention_name>
    <description>Procedure: Transcatheter aortic valve replacement (TAVR)</description>
    <arm_group_label>CoreValve TAVR System - Randomized</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LOTUS Edge Valve System</intervention_name>
    <description>Procedure: Transcatheter aortic valve replacement (TAVR)</description>
    <arm_group_label>LOTUS Edge Valve System - Single-arm Edge Nested Registry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has documented calcific, severe native aortic stenosis with an initial aortic&#xD;
             valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure&#xD;
             gradient &gt;40 mm Hg or jet velocity &gt;4.0 m/s, as measured by echocardiography and/or&#xD;
             invasive hemodynamics&#xD;
&#xD;
          2. Subject has a documented aortic annulus size of ≥18 mm and ≤29 mm based on the&#xD;
             center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case&#xD;
             Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an&#xD;
             available size of both test and control device. For the U.S. Continued Access Study&#xD;
             cohort the acceptable aortic annulus size is ≥20 mm and ≤27 mm.&#xD;
&#xD;
          3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA)&#xD;
             Functional Class ≥ II&#xD;
&#xD;
          4. There is agreement by the heart team (which must include a site investigator&#xD;
             interventionalist and a site investigator cardiac surgeon) that subject is at high or&#xD;
             extreme operative risk for surgical valve replacement (see note below for definitions&#xD;
             of extreme and high risk, the required level of surgical assessment, and CRC&#xD;
             confirmation) and that TAVR is appropriate. Additionally, subject has at least one of&#xD;
             the following.&#xD;
&#xD;
               -  Society of Thoracic Surgeons (STS) score ≥8% -OR-&#xD;
&#xD;
               -  If STS &lt;8, subject has at least one of the following conditions: Hostile chest,&#xD;
                  porcelain aorta, severe pulmonary hypertension (&gt;60 mmHg), prior chest radiation&#xD;
                  therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung&#xD;
                  disease (need for supplemental oxygen, forced expiratory volume in 1 second&#xD;
                  [FEV1] &lt;50% of predicted, diffusing capacity of the lungs for carbon monoxide&#xD;
                  [DLCO] &lt;60%, or other evidence of severe pulmonary dysfunction), neuromuscular&#xD;
                  disease that creates risk for mechanical ventilation or rehabilitation after&#xD;
                  surgical aortic valve replacement, orthopedic disease that creates risk for&#xD;
                  rehabilitation after surgical aortic valve replacement, Childs Class A or B liver&#xD;
                  disease (subjects with Childs Class C disease are not eligible for inclusion in&#xD;
                  this trial), frailty as indicated by at least one of the following: 5-meter walk&#xD;
                  &gt;6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body&#xD;
                  mass index &lt;21, wheelchair bound, unable to live independently, age ≥90 years,&#xD;
                  other evidence that subject is at high or extreme risk for surgical valve&#xD;
                  replacement (CRC must confirm agreement with site heart team that subject meets&#xD;
                  high or extreme risk definition)&#xD;
&#xD;
          5. Heart team (which must include a cardiac interventionalist and an experienced cardiac&#xD;
             surgeon) assessment that the subject is likely to benefit from valve replacement.&#xD;
&#xD;
          6. Subject (or legal representative) understands the study requirements and the treatment&#xD;
             procedures, and provides written informed consent.&#xD;
&#xD;
          7. Subject, family member, and/or legal representative agree(s) and subject is capable of&#xD;
             returning to the study hospital for all required scheduled follow up visits.&#xD;
&#xD;
        Note: Extreme operative risk and high operative risk are defined as follows: Extreme&#xD;
        Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50%&#xD;
        at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible&#xD;
        morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed&#xD;
        via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC&#xD;
        (which must include an experienced cardiac surgeon).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a congenital unicuspid or bicuspid aortic valve.&#xD;
&#xD;
          2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index&#xD;
             procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK)&#xD;
             elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB)&#xD;
             elevation and/or troponin elevation).&#xD;
&#xD;
          3. Subject has had a cerebrovascular accident or transient ischemic attack within the&#xD;
             past 6 months prior to study enrollment.&#xD;
&#xD;
          4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) &lt;20 (based&#xD;
             on Cockcroft-Gault formula).&#xD;
&#xD;
          5. Subject has a pre-existing prosthetic aortic or mitral valve.&#xD;
&#xD;
          6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.&#xD;
&#xD;
          7. Subject has a need for emergency surgery for any reason.&#xD;
&#xD;
          8. Subject has a history of endocarditis within 6 months of index procedure or evidence&#xD;
             of an active systemic infection or sepsis.&#xD;
&#xD;
          9. Subject has echocardiographic evidence of new intra-cardiac mass, vegetation or&#xD;
             intraventricular or paravalvular thrombus requiring intervention.&#xD;
&#xD;
         10. Subject has (hemoglobin) Hgb &lt;9 g/dL, platelet count &lt;50,000 cells/mm3 or &gt;700,000&#xD;
             cells/mm3, or white blood cell count &lt;1,000 cells/mm3.&#xD;
&#xD;
         11. Subject requires chronic anticoagulation therapy after the implant procedure and&#xD;
             cannot be treated with warfarin (other anticoagulants are not permitted in the first&#xD;
             month) for at least 1 month concomitant with either aspirin or clopidogrel.&#xD;
&#xD;
         12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion&#xD;
             within the past 3 months, or has other clinically significant bleeding diathesis or&#xD;
             coagulopathy that would preclude treatment with required antiplatelet regimen, or will&#xD;
             refuse transfusions.&#xD;
&#xD;
         13. Subject has known hypersensitivity to contrast agents that cannot be adequately&#xD;
             pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors,&#xD;
             heparin, nickel, tantalum, titanium, or polyurethanes.&#xD;
&#xD;
         14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid&#xD;
             conditions based on the assessment of the investigator at the time of enrollment.&#xD;
&#xD;
         15. Subject has hypertrophic obstructive cardiomyopathy.&#xD;
&#xD;
         16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days&#xD;
             prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker&#xD;
             implantation, which are allowed).&#xD;
&#xD;
         17. Subject has untreated coronary artery disease, which in the opinion of the treating&#xD;
             physician is clinically significant and requires revascularization.&#xD;
&#xD;
         18. Subject has severe left ventricular dysfunction with ejection fraction &lt;20%.&#xD;
&#xD;
         19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic&#xD;
             support or mechanical support devices.&#xD;
&#xD;
         20. Subject has severe vascular disease that would preclude safe access (e.g., aneurysm&#xD;
             with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing&#xD;
             of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid&#xD;
             or vertebral disease).&#xD;
&#xD;
         21. Subject has thick (&gt;5 mm) protruding or ulcerated atheroma in the aortic arch&#xD;
&#xD;
         22. Subject has arterial access that is not acceptable for the test and control device&#xD;
             delivery systems as defined in the device Instructions For Use.&#xD;
&#xD;
         23. Subject has current problems with substance abuse (e.g., alcohol, etc.).&#xD;
&#xD;
         24. Subject is participating in another investigational drug or device study that has not&#xD;
             reached its primary endpoint.&#xD;
&#xD;
         25. Subject has untreated conduction system disorder (e.g., Type II second degree&#xD;
             atrioventricular block) that in the opinion of the treating physician is clinically&#xD;
             significant and requires a pacemaker implantation. Enrollment is permissible after&#xD;
             permanent pacemaker implantation.&#xD;
&#xD;
         26. Subject has severe incapacitating dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Rizik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scottsdale Healthcare - Shea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael J Reardon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Methodist Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Good Samaritan</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scottsdale Healthcare - Shea</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Clinic</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veteran's Administration Palo Alto Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Mease Healthcare System</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delray Medical Center</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Cardiac and Vascular Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evanston Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Hospital - Prairie Cardiovascular Consultants</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac &amp; Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital - Minneapolis Heart Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine - Barnes Jewish Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Memorial Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaleida Health</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular Research - Rex Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center for Research and Education at The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Health Research and Innovation Institute - Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence St. Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Heart and Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist DeBakey Heart &amp; Vascular Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Heart Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St. Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health - St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre, Royal Victoria Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <state>Midi-Pyrenees</state>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hôpital Universitaire Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universität Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitares Herzzentrum UKE (Hamburg)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC - University Medical Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>May 17, 2019</results_first_submitted>
  <results_first_submitted_qc>July 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2019</results_first_posted>
  <disposition_first_submitted>October 16, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>October 16, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 19, 2017</disposition_first_posted>
  <last_update_submitted>December 15, 2021</last_update_submitted>
  <last_update_submitted_qc>December 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02202434/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>912 subjects randomized from 22Sep2014 to 24Dec2015. 102 subjects enrolled in the Roll-in cohort. 295 subjects enrolled in the US CAS from 25Feb2016 to 23Feb2017. Enrollment in the LOTUS Edge Valve System - Single-arm Edge Nested Reg is ongoing.&#xD;
Enrollment in the LOTUS Edge Valve System - Single-arm 29mm Reg and Roll-in Cohorts has not begun.</recruitment_details>
      <pre_assignment_details>The non-randomized Roll-In phase with only the test device was for centers with no previous experience implanting the Lotus Valve System. Each performed at least two Roll-In cases before starting RCT.&#xD;
Only cohorts that have completed enrollment, reached primary endpoint and were submitted for regulatory approval are included in the Results Section</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lotus Valve System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="P2">
          <title>CoreValve TAVR System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="P3">
          <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="P4">
          <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="607"/>
                <participants group_id="P2" count="305"/>
                <participants group_id="P3" count="102"/>
                <participants group_id="P4" count="295"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="498"/>
                <participants group_id="P2" count="236"/>
                <participants group_id="P3" count="87"/>
                <participants group_id="P4" count="258"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Completed Study</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Visit Missed</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data are reported separately for each cohort as pooled mean and standard deviations across cohorts do not provide meaningful data.</population>
      <group_list>
        <group group_id="B1">
          <title>Lotus Valve System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="B2">
          <title>CoreValve TAVR System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="B3">
          <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="B4">
          <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="B5">
          <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="607"/>
            <count group_id="B2" value="305"/>
            <count group_id="B3" value="102"/>
            <count group_id="B4" value="295"/>
            <count group_id="B5" value="1309"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Lotus Valve System - Randomized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.8" spread="7.1"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="82.8" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CoreValve TAVR System - Randomize</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="82.9" spread="7.6"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="82.9" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="83.6" spread="6.9"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="83.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Continued Access</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="81.7" spread="6.6"/>
                    <measurement group_id="B5" value="81.7" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="304"/>
                    <measurement group_id="B2" value="159"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="137"/>
                    <measurement group_id="B5" value="652"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="158"/>
                    <measurement group_id="B5" value="657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Subjects were allowed to select more than one option.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black, of African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="537"/>
                    <measurement group_id="B2" value="271"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="271"/>
                    <measurement group_id="B5" value="1172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="531"/>
                    <measurement group_id="B2" value="261"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="295"/>
                    <measurement group_id="B5" value="1187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Society of Thoracic Surgeons (STS) Risk Score</title>
          <description>The Society of Thoracic Surgeons Score is a risk model used to predict a subject's risk of mortality and morbidities for the most commonly performed cardiac surgeries. The model is a percentage score from 0 to 100 where a lower score means a lower risk and higher score means a higher risk.</description>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Lotus Valve System - Randomized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.7" spread="4.0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="6.7" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CoreValve TAVR System - Randomized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="6.9" spread="4.1"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="6.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="7.0" spread="4.9"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="7.0" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Continued Access</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="5.4" spread="2.9"/>
                    <measurement group_id="B5" value="5.4" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>European System for Cardiac Operative Risk Evaluation (EuroSCORE)</title>
          <description>The European System for Cardiac Operative Risk Evaluation is a risk model where if a risk factor is present in a subject, a weight or number is assigned. The weights are added to give an approximate percent predicted mortality. A higher score means a higher risk and a lower score means a lower risk.</description>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Lotus Valve System - Randomized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.4" spread="5.5"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="6.4" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CoreValve TAVR System - Randomized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="6.4" spread="5.5"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="6.4" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="6.4" spread="6.5"/>
                    <measurement group_id="B4" value="0" spread="0"/>
                    <measurement group_id="B5" value="6.4" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lotus Valve System - Single-arm Continued Access</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="5.3" spread="5.9"/>
                    <measurement group_id="B5" value="5.3" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Classification</title>
          <description>New York Heart Association Classification is a system for defining cardiac disease and related functional limitations into four broad categorizations. The categories range from NYHA I (No limitations) to NYHA IV (inability to carry out any physical activity without discomfort).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NYHA I</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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="108"/>
                    <measurement group_id="B5" value="402"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="386"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="171"/>
                    <measurement group_id="B5" value="813"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Events Included in the Primary Safety Endpoint</title>
        <description>Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications</description>
        <time_frame>30 days following procedure</time_frame>
        <population>Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Events Included in the Primary Safety Endpoint</title>
          <description>Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications</description>
          <population>Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="577"/>
                <count group_id="O2" value="297"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3"/>
                    <measurement group_id="O2" value="17.2"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>10.5% non-inferiority margin</non_inferiority_desc>
            <p_value>0.0027</p_value>
            <method>Farrington-Manning</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>3.1</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>8.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Events Included in the Primary Effectiveness Endpoint</title>
        <description>Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).</description>
        <time_frame>1 year following procedure</time_frame>
        <population>Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.&#xD;
Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Events Included in the Primary Effectiveness Endpoint</title>
          <description>Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).</description>
          <population>Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.&#xD;
Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Implanted</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="577"/>
                    <count group_id="O2" value="297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intent to Treat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="607"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                    <measurement group_id="O2" value="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>9.5% Non-Inferiority margin</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>Farrington-Manning</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-10.1</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>-4.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Superiority analysis was only to be run if the non-inferiority analysis was met.&#xD;
Superiority analysis was run on Intent to Treat Population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Chi-squared</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-10.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.3</ci_lower_limit>
            <ci_upper_limit>-4.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation</title>
        <description>Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).</description>
        <time_frame>1 year following procedure</time_frame>
        <population>ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted.&#xD;
The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation</title>
          <description>Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).</description>
          <population>ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted.&#xD;
The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="6.9"/>
                  </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>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-6.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.6</ci_lower_limit>
            <ci_upper_limit>-2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Successful Deployment of the Study Valve</title>
        <description>Successful deployment of the study valve</description>
        <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Successful Deployment of the Study Valve</title>
          <description>Successful deployment of the study valve</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8"/>
                    <measurement group_id="O2" value="99.0"/>
                    <measurement group_id="O3" value="99.0"/>
                    <measurement group_id="O4" value="96.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted</title>
        <description>Successful retrieval of the study valve if retrieval is attempted</description>
        <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
        <population>Number of Intent to Treat participants who had Retrieval attempted</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted</title>
          <description>Successful retrieval of the study valve if retrieval is attempted</description>
          <population>Number of Intent to Treat participants who had Retrieval attempted</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted</title>
        <description>Successful repositioning of the study valve if repositioning is attempted</description>
        <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
        <population>Number of Intent to Treat participants who had Repositioning attempted</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted</title>
          <description>Successful repositioning of the study valve if repositioning is attempted</description>
          <population>Number of Intent to Treat participants who had Repositioning attempted</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="97.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined</title>
        <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
        <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined</title>
          <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
          <population>Intent to Treat</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2"/>
                    <measurement group_id="O2" value="8.7"/>
                    <measurement group_id="O3" value="15.8"/>
                    <measurement group_id="O4" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8"/>
                    <measurement group_id="O2" value="91.3"/>
                    <measurement group_id="O3" value="84.2"/>
                    <measurement group_id="O4" value="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                    <measurement group_id="O2" value="1.8"/>
                    <measurement group_id="O3" value="6.3"/>
                    <measurement group_id="O4" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="3.2"/>
                    <measurement group_id="O4" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.4"/>
                    <measurement group_id="O3" value="1.1"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.4"/>
                    <measurement group_id="O3" value="1.1"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central - AR but Severity Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                    <measurement group_id="O2" value="5.8"/>
                    <measurement group_id="O3" value="5.3"/>
                    <measurement group_id="O4" value="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="72.6"/>
                    <measurement group_id="O3" value="28.4"/>
                    <measurement group_id="O4" value="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1"/>
                    <measurement group_id="O2" value="27.4"/>
                    <measurement group_id="O3" value="71.6"/>
                    <measurement group_id="O4" value="71.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                    <measurement group_id="O2" value="18.1"/>
                    <measurement group_id="O3" value="12.6"/>
                    <measurement group_id="O4" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="46.9"/>
                    <measurement group_id="O3" value="12.6"/>
                    <measurement group_id="O4" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paravalvular - AR but Severity Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="4.0"/>
                    <measurement group_id="O3" value="3.2"/>
                    <measurement group_id="O4" value="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1"/>
                    <measurement group_id="O2" value="73.3"/>
                    <measurement group_id="O3" value="36.8"/>
                    <measurement group_id="O4" value="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.9"/>
                    <measurement group_id="O2" value="26.7"/>
                    <measurement group_id="O3" value="63.2"/>
                    <measurement group_id="O4" value="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4"/>
                    <measurement group_id="O2" value="18.4"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="48.7"/>
                    <measurement group_id="O3" value="15.8"/>
                    <measurement group_id="O4" value="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="4.3"/>
                    <measurement group_id="O3" value="1.1"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="4.3"/>
                    <measurement group_id="O3" value="1.1"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - AR but Severity Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="1.8"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Clinical Procedural Success</title>
        <description>Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding</description>
        <time_frame>30 days post procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Procedural Success</title>
          <description>Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding</description>
          <population>Intent to Treat</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4"/>
                    <measurement group_id="O2" value="84.6"/>
                    <measurement group_id="O3" value="81.4"/>
                    <measurement group_id="O4" value="81.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Procedural Success</title>
        <description>Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] &gt;0.9 cm2 for body surface area (BSA) &lt;1.6 m2 and EOA &gt;1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient &lt;20 mm Hg or a peak velocity &lt;3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events</description>
        <time_frame>30 days post procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Procedural Success</title>
          <description>Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] &gt;0.9 cm2 for body surface area (BSA) &lt;1.6 m2 and EOA &gt;1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient &lt;20 mm Hg or a peak velocity &lt;3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0"/>
                    <measurement group_id="O2" value="39.2"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1</title>
        <description>Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1</title>
          <description>Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity</description>
          <population>Intent to Treat</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge or 7 Days - Aortic Valve Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread="0.47"/>
                    <measurement group_id="O2" value="1.96" spread="0.52"/>
                    <measurement group_id="O3" value="1.70" spread="0.49"/>
                    <measurement group_id="O4" value="1.61" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days - Aortic Valve Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.59" spread="0.45"/>
                    <measurement group_id="O2" value="1.98" spread="0.51"/>
                    <measurement group_id="O3" value="1.62" spread="0.46"/>
                    <measurement group_id="O4" value="1.55" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months - Aortic Valve Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.46"/>
                    <measurement group_id="O2" value="1.74" spread="0.55"/>
                    <measurement group_id="O3" value="1.55" spread="0.45"/>
                    <measurement group_id="O4" value="1.56" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Aortic Valve Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="0.45"/>
                    <measurement group_id="O2" value="1.69" spread="0.52"/>
                    <measurement group_id="O3" value="1.53" spread="0.49"/>
                    <measurement group_id="O4" value="1.51" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2</title>
        <description>Assessed by an independent core laboratory - mean and peak aortic gradients</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2</title>
          <description>Assessed by an independent core laboratory - mean and peak aortic gradients</description>
          <population>Intent to Treat</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge or 7 Days - Mean Aortic Valve Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.20" spread="5.21"/>
                    <measurement group_id="O2" value="8.19" spread="3.98"/>
                    <measurement group_id="O3" value="12.13" spread="5.13"/>
                    <measurement group_id="O4" value="12.50" spread="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge or 7 Days - Peak Aortic Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.28" spread="10.23"/>
                    <measurement group_id="O2" value="15.21" spread="7.20"/>
                    <measurement group_id="O3" value="21.58" spread="8.55"/>
                    <measurement group_id="O4" value="22.89" spread="10.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days - Mean Aortic Valve Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.00" spread="6.08"/>
                    <measurement group_id="O2" value="7.25" spread="3.44"/>
                    <measurement group_id="O3" value="12.76" spread="8.24"/>
                    <measurement group_id="O4" value="12.24" spread="6.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days - Peak Aortic Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.46" spread="10.27"/>
                    <measurement group_id="O2" value="13.59" spread="6.21"/>
                    <measurement group_id="O3" value="23.02" spread="13.43"/>
                    <measurement group_id="O4" value="22.56" spread="11.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months - Mean Aortic Valve Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.93" spread="5.21"/>
                    <measurement group_id="O2" value="7.89" spread="4.24"/>
                    <measurement group_id="O3" value="12.33" spread="5.89"/>
                    <measurement group_id="O4" value="12.20" spread="5.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months - Peak Aortic Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.24" spread="9.82"/>
                    <measurement group_id="O2" value="14.84" spread="7.46"/>
                    <measurement group_id="O3" value="22.85" spread="10.60"/>
                    <measurement group_id="O4" value="22.68" spread="9.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Mean Aortic Valve Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.29" spread="5.83"/>
                    <measurement group_id="O2" value="7.89" spread="3.48"/>
                    <measurement group_id="O3" value="12.30" spread="7.39"/>
                    <measurement group_id="O4" value="12.68" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Peak Aortic Gradient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.74" spread="10.53"/>
                    <measurement group_id="O2" value="15.22" spread="6.44"/>
                    <measurement group_id="O3" value="22.03" spread="12.05"/>
                    <measurement group_id="O4" value="23.75" spread="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3</title>
        <description>Assessed by an independent core laboratory - peak aortic velocity</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3</title>
          <description>Assessed by an independent core laboratory - peak aortic velocity</description>
          <population>Intent to Treat</population>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge or 7 Days - Peak Aortic Velocity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.48"/>
                    <measurement group_id="O2" value="1.89" spread="0.45"/>
                    <measurement group_id="O3" value="2.28" spread="0.44"/>
                    <measurement group_id="O4" value="2.33" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days - Peak Aortic Velocity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" spread="0.46"/>
                    <measurement group_id="O2" value="1.80" spread="0.40"/>
                    <measurement group_id="O3" value="2.33" spread="0.58"/>
                    <measurement group_id="O4" value="2.31" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months - Peak Aortic Velocity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.46"/>
                    <measurement group_id="O2" value="1.87" spread="0.44"/>
                    <measurement group_id="O3" value="2.32" spread="0.49"/>
                    <measurement group_id="O4" value="2.33" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year - Peak Aortic Velocity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.51"/>
                    <measurement group_id="O2" value="1.91" spread="0.41"/>
                    <measurement group_id="O3" value="2.28" spread="0.55"/>
                    <measurement group_id="O4" value="2.39" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4</title>
        <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4</title>
          <description>Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.&#xD;
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Paravalvular - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="72.6"/>
                    <measurement group_id="O3" value="28.4"/>
                    <measurement group_id="O4" value="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1"/>
                    <measurement group_id="O2" value="27.4"/>
                    <measurement group_id="O3" value="71.6"/>
                    <measurement group_id="O4" value="71.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                    <measurement group_id="O2" value="18.1"/>
                    <measurement group_id="O3" value="12.6"/>
                    <measurement group_id="O4" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="46.9"/>
                    <measurement group_id="O3" value="12.6"/>
                    <measurement group_id="O4" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Paravalvular Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge ParavalvularAR but Severity not evaluabl</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="4.0"/>
                    <measurement group_id="O3" value="3.2"/>
                    <measurement group_id="O4" value="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5"/>
                    <measurement group_id="O2" value="75.5"/>
                    <measurement group_id="O3" value="30.0"/>
                    <measurement group_id="O4" value="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5"/>
                    <measurement group_id="O2" value="24.5"/>
                    <measurement group_id="O3" value="70.0"/>
                    <measurement group_id="O4" value="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7"/>
                    <measurement group_id="O2" value="14.7"/>
                    <measurement group_id="O3" value="10.0"/>
                    <measurement group_id="O4" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7"/>
                    <measurement group_id="O2" value="48.7"/>
                    <measurement group_id="O3" value="15.0"/>
                    <measurement group_id="O4" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="7.2"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="7.2"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Paravalvular AR but Severity not evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="4.9"/>
                    <measurement group_id="O3" value="4.0"/>
                    <measurement group_id="O4" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3"/>
                    <measurement group_id="O2" value="62.7"/>
                    <measurement group_id="O3" value="23.8"/>
                    <measurement group_id="O4" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.7"/>
                    <measurement group_id="O2" value="37.3"/>
                    <measurement group_id="O3" value="76.2"/>
                    <measurement group_id="O4" value="73.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="6.8"/>
                    <measurement group_id="O3" value="7.1"/>
                    <measurement group_id="O4" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="42.4"/>
                    <measurement group_id="O3" value="14.3"/>
                    <measurement group_id="O4" value="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="4.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="4.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Paravalvular AR but Severity not evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="8.9"/>
                    <measurement group_id="O3" value="2.4"/>
                    <measurement group_id="O4" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular - Trace or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1"/>
                    <measurement group_id="O2" value="63.0"/>
                    <measurement group_id="O3" value="24.4"/>
                    <measurement group_id="O4" value="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9"/>
                    <measurement group_id="O2" value="37.0"/>
                    <measurement group_id="O3" value="75.6"/>
                    <measurement group_id="O4" value="79.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Trace/Trivial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="10.5"/>
                    <measurement group_id="O3" value="4.7"/>
                    <measurement group_id="O4" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="38.8"/>
                    <measurement group_id="O3" value="14.0"/>
                    <measurement group_id="O4" value="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Mild-Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="5.9"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Moderate-Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.9"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular Moderate or Greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="6.8"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Paravalvular AR but Severity not evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="6.8"/>
                    <measurement group_id="O3" value="5.8"/>
                    <measurement group_id="O4" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Health Status as Evaluated by Quality of Life Questionnaires</title>
        <description>SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year&#xD;
SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.&#xD;
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
        <time_frame>Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Health Status as Evaluated by Quality of Life Questionnaires</title>
          <description>SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year&#xD;
SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.&#xD;
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
          <population>Intent to Treat</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SF-12 Physical Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="9.0"/>
                    <measurement group_id="O2" value="31.2" spread="8.9"/>
                    <measurement group_id="O3" value="33.8" spread="10.5"/>
                    <measurement group_id="O4" value="32.4" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline SF-12 Mental Health Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.6" spread="11.6"/>
                    <measurement group_id="O2" value="49.0" spread="11.6"/>
                    <measurement group_id="O3" value="49.8" spread="11.0"/>
                    <measurement group_id="O4" value="50.0" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline KC Overall Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9" spread="23.5"/>
                    <measurement group_id="O2" value="50.7" spread="22.1"/>
                    <measurement group_id="O3" value="52.7" spread="24.6"/>
                    <measurement group_id="O4" value="53.5" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline KC Clinical Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.2" spread="23.3"/>
                    <measurement group_id="O2" value="54.9" spread="21.9"/>
                    <measurement group_id="O3" value="57.3" spread="23.7"/>
                    <measurement group_id="O4" value="57.6" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day change from Baseline SF-12 Physical Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="10.5"/>
                    <measurement group_id="O2" value="6.0" spread="10.0"/>
                    <measurement group_id="O3" value="3.3" spread="10.5"/>
                    <measurement group_id="O4" value="4.3" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day change from Baseline SF-12 Mental Health S</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="12.5"/>
                    <measurement group_id="O2" value="2.3" spread="12.6"/>
                    <measurement group_id="O3" value="1.8" spread="11.3"/>
                    <measurement group_id="O4" value="3.2" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day change from Baseline KC Overall Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="24.2"/>
                    <measurement group_id="O2" value="20.2" spread="24.0"/>
                    <measurement group_id="O3" value="17.4" spread="25.6"/>
                    <measurement group_id="O4" value="18.3" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day change from Baseline KC Clinical Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="23.9"/>
                    <measurement group_id="O2" value="16.6" spread="22.9"/>
                    <measurement group_id="O3" value="15.2" spread="24.5"/>
                    <measurement group_id="O4" value="14.8" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6M change from Baseline SF-12 Physical Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="10.8"/>
                    <measurement group_id="O2" value="5.6" spread="10.1"/>
                    <measurement group_id="O3" value="3.6" spread="9.8"/>
                    <measurement group_id="O4" value="4.7" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6M change from Baseline SF-12 Mental Health Sum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="11.2"/>
                    <measurement group_id="O2" value="3.3" spread="12.6"/>
                    <measurement group_id="O3" value="2.8" spread="10.5"/>
                    <measurement group_id="O4" value="3.3" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6M change from Baseline KC Overal Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="23.8"/>
                    <measurement group_id="O2" value="22.7" spread="22.6"/>
                    <measurement group_id="O3" value="23.5" spread="25.5"/>
                    <measurement group_id="O4" value="21.2" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6M change from Baseline KC Clinical Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" spread="22.7"/>
                    <measurement group_id="O2" value="17.0" spread="22.2"/>
                    <measurement group_id="O3" value="17.5" spread="24.0"/>
                    <measurement group_id="O4" value="15.9" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1Y change from Baseline SF-12 Physical Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="10.9"/>
                    <measurement group_id="O2" value="5.2" spread="10.1"/>
                    <measurement group_id="O3" value="3.0" spread="10.8"/>
                    <measurement group_id="O4" value="3.7" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1Y change from Baseline SF-12 Mental Health Sum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="11.5"/>
                    <measurement group_id="O2" value="3.7" spread="12.9"/>
                    <measurement group_id="O3" value="3.2" spread="12.5"/>
                    <measurement group_id="O4" value="3.0" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1Y change from Baseline KC Overall Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="24.4"/>
                    <measurement group_id="O2" value="21.4" spread="23.2"/>
                    <measurement group_id="O3" value="23.2" spread="26.7"/>
                    <measurement group_id="O4" value="20.0" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1Y change from Baseline KC Clinical Summary Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="23.8"/>
                    <measurement group_id="O2" value="15.0" spread="21.5"/>
                    <measurement group_id="O3" value="15.6" spread="26.8"/>
                    <measurement group_id="O4" value="14.0" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Mortality</title>
        <description>All-cause, Cardiovascular, and Non-cardiovascular</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Mortality</title>
          <description>All-cause, Cardiovascular, and Non-cardiovascular</description>
          <population>Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge All Cause Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="607"/>
                    <count group_id="O2" value="305"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="607"/>
                    <count group_id="O2" value="305"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Non-Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="607"/>
                    <count group_id="O2" value="305"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day All Cause Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="601"/>
                    <count group_id="O2" value="303"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="2.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="601"/>
                    <count group_id="O2" value="303"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="2.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Non-Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="601"/>
                    <count group_id="O2" value="303"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month All Cause Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="594"/>
                    <count group_id="O2" value="300"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="8.3"/>
                    <measurement group_id="O3" value="8.8"/>
                    <measurement group_id="O4" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="594"/>
                    <count group_id="O2" value="300"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="6.7"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Non-Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="594"/>
                    <count group_id="O2" value="300"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="1.7"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year All Cause Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="587"/>
                    <count group_id="O2" value="297"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                    <measurement group_id="O2" value="13.5"/>
                    <measurement group_id="O3" value="12.9"/>
                    <measurement group_id="O4" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="587"/>
                    <count group_id="O2" value="297"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="9.8"/>
                    <measurement group_id="O3" value="7.9"/>
                    <measurement group_id="O4" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Non-Cardiovascular Mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="587"/>
                    <count group_id="O2" value="297"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="3.7"/>
                    <measurement group_id="O3" value="5.0"/>
                    <measurement group_id="O4" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Stroke</title>
        <description>Disabling Stroke and Non-disabling Stroke</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Stroke</title>
          <description>Disabling Stroke and Non-disabling Stroke</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge All Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="4.3"/>
                    <measurement group_id="O3" value="3.9"/>
                    <measurement group_id="O4" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                    <measurement group_id="O2" value="3.3"/>
                    <measurement group_id="O3" value="3.9"/>
                    <measurement group_id="O4" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Non-Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day All Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="4.3"/>
                    <measurement group_id="O3" value="4.9"/>
                    <measurement group_id="O4" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="3.3"/>
                    <measurement group_id="O3" value="3.9"/>
                    <measurement group_id="O4" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Non-Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month All Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="8.3"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Non-Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year All Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                    <measurement group_id="O2" value="9.4"/>
                    <measurement group_id="O3" value="7.9"/>
                    <measurement group_id="O4" value="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="7.1"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Non-Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="2.4"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Myocardial Infarction (MI)</title>
        <description>Periprocedural (≤72 hours post index procedure) and spontaneous (&gt;72 hours post index procedure)</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Myocardial Infarction (MI)</title>
          <description>Periprocedural (≤72 hours post index procedure) and spontaneous (&gt;72 hours post index procedure)</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Peri-procedural MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Spontaneous MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Peri-procedural MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Spontaneous MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="3.0"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Peri-procedural MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Spontaneous MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                    <measurement group_id="O2" value="4.4"/>
                    <measurement group_id="O3" value="5.0"/>
                    <measurement group_id="O4" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Peri-procedural MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Spontaneous MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="3.4"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Bleeding</title>
        <description>Life-threatening (or disabling) and major (defined below)&#xD;
Life-threatening or Disabling Bleeding&#xD;
Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)&#xD;
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)&#xD;
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)&#xD;
Major Bleeding (BARC type 3a)&#xD;
Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Bleeding</title>
          <description>Life-threatening (or disabling) and major (defined below)&#xD;
Life-threatening or Disabling Bleeding&#xD;
Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)&#xD;
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)&#xD;
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)&#xD;
Major Bleeding (BARC type 3a)&#xD;
Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                    <measurement group_id="O2" value="10.5"/>
                    <measurement group_id="O3" value="8.8"/>
                    <measurement group_id="O4" value="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Life-threatening or Disabling Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                    <measurement group_id="O2" value="5.9"/>
                    <measurement group_id="O3" value="7.8"/>
                    <measurement group_id="O4" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="4.6"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="10.9"/>
                    <measurement group_id="O3" value="11.8"/>
                    <measurement group_id="O4" value="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Life-threatening or Disabling Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="5.0"/>
                    <measurement group_id="O3" value="9.8"/>
                    <measurement group_id="O4" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="5.9"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5"/>
                    <measurement group_id="O2" value="17.0"/>
                    <measurement group_id="O3" value="17.6"/>
                    <measurement group_id="O4" value="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Life-threatening or Disabling Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3"/>
                    <measurement group_id="O2" value="9.0"/>
                    <measurement group_id="O3" value="14.7"/>
                    <measurement group_id="O4" value="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                    <measurement group_id="O2" value="8.0"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1"/>
                    <measurement group_id="O2" value="17.8"/>
                    <measurement group_id="O3" value="20.8"/>
                    <measurement group_id="O4" value="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Life-threatening or Disabling Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9"/>
                    <measurement group_id="O2" value="9.8"/>
                    <measurement group_id="O3" value="16.8"/>
                    <measurement group_id="O4" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="8.4"/>
                    <measurement group_id="O3" value="5.0"/>
                    <measurement group_id="O4" value="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Acute Kidney Injury</title>
        <description>Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2&#xD;
Change in serum creatinine (up to 7 days) compared to baseline:&#xD;
Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)&#xD;
Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)&#xD;
Stage 3: Increase in serum creatinine to ≥300% (&gt;3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)&#xD;
-OR-&#xD;
Based on urine output (up to 7 days):&#xD;
Stage 1: &lt;0.5 ml/kg per hour for &gt;6 but &lt;12 hours&#xD;
Stage 2: &lt;0.5 ml/kg per hour for &gt;12 but &lt;24 hours&#xD;
Stage 3: &lt;0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours&#xD;
Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.</description>
        <time_frame>≤7 days post index procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Acute Kidney Injury</title>
          <description>Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2&#xD;
Change in serum creatinine (up to 7 days) compared to baseline:&#xD;
Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)&#xD;
Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)&#xD;
Stage 3: Increase in serum creatinine to ≥300% (&gt;3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)&#xD;
-OR-&#xD;
Based on urine output (up to 7 days):&#xD;
Stage 1: &lt;0.5 ml/kg per hour for &gt;6 but &lt;12 hours&#xD;
Stage 2: &lt;0.5 ml/kg per hour for &gt;12 but &lt;24 hours&#xD;
Stage 3: &lt;0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours&#xD;
Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute Kidney Injury - Stage 2 or Stage 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage 3 (including renal replacement therapy)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="2.3"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Major Vascular Complication</title>
        <description>Major vascular complication - including access site related and non access site related</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Major Vascular Complication</title>
          <description>Major vascular complication - including access site related and non access site related</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Major Vascular Complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="5.6"/>
                    <measurement group_id="O3" value="8.8"/>
                    <measurement group_id="O4" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="3.6"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Not Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Major Vascular Complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                    <measurement group_id="O2" value="5.3"/>
                    <measurement group_id="O3" value="8.8"/>
                    <measurement group_id="O4" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                    <measurement group_id="O2" value="3.3"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Not Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Major Vascular Complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="5.7"/>
                    <measurement group_id="O3" value="8.8"/>
                    <measurement group_id="O4" value="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="3.7"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Not Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Major Vascular Complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="6.1"/>
                    <measurement group_id="O3" value="8.9"/>
                    <measurement group_id="O4" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="3.7"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Not Access Site Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="2.4"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Repeat Procedure for Valve-related Dysfunction</title>
        <description>Repeat procedure for valve-related dysfunction (surgical or interventional therapy)</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Repeat Procedure for Valve-related Dysfunction</title>
          <description>Repeat procedure for valve-related dysfunction (surgical or interventional therapy)</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Repeat proc valve-related dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Repeat proc valve-related dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Repeat proc valve-related dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="1.7"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Repeat proc valve-related dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure</title>
        <description>Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure</title>
          <description>Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="3.0"/>
                    <measurement group_id="O3" value="4.9"/>
                    <measurement group_id="O4" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="9.3"/>
                    <measurement group_id="O3" value="9.8"/>
                    <measurement group_id="O4" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2"/>
                    <measurement group_id="O2" value="13.8"/>
                    <measurement group_id="O3" value="13.9"/>
                    <measurement group_id="O4" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With New Permanent Pacemaker Implantation</title>
        <description>New permanent pacemaker implantation resulting from new or worsened conduction disturbances</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With New Permanent Pacemaker Implantation</title>
          <description>New permanent pacemaker implantation resulting from new or worsened conduction disturbances</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2"/>
                    <measurement group_id="O2" value="14.8"/>
                    <measurement group_id="O3" value="27.5"/>
                    <measurement group_id="O4" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1"/>
                    <measurement group_id="O2" value="15.8"/>
                    <measurement group_id="O3" value="28.4"/>
                    <measurement group_id="O4" value="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="18.0"/>
                    <measurement group_id="O3" value="29.4"/>
                    <measurement group_id="O4" value="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2"/>
                    <measurement group_id="O2" value="18.5"/>
                    <measurement group_id="O3" value="30.7"/>
                    <measurement group_id="O4" value="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter</title>
        <description>New onset of atrial fibrillation or atrial flutter</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter</title>
          <description>New onset of atrial fibrillation or atrial flutter</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4"/>
                    <measurement group_id="O2" value="3.9"/>
                    <measurement group_id="O3" value="4.9"/>
                    <measurement group_id="O4" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="4.3"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="4.7"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="4.7"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Coronary Obstruction</title>
        <description>Coronary obstruction</description>
        <time_frame>≤72 hours post index procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Coronary Obstruction</title>
          <description>Coronary obstruction</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Ventricular Septal Perforation</title>
        <description>Ventricular septal perforation</description>
        <time_frame>≤72 hours post index procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Ventricular Septal Perforation</title>
          <description>Ventricular septal perforation</description>
          <population>Intent to Treat</population>
          <units>Percentage of participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Mitral Apparatus Damage</title>
        <description>Mitral apparatus damage</description>
        <time_frame>≤72 hours post index procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Mitral Apparatus Damage</title>
          <description>Mitral apparatus damage</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Cardiac Tamponade</title>
        <description>Cardiac tamponade</description>
        <time_frame>≤72 hours post index procedure</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cardiac Tamponade</title>
          <description>Cardiac tamponade</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Prosthetic Aortic Valve Malpositioning</title>
        <description>Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Prosthetic Aortic Valve Malpositioning</title>
          <description>Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge Prosthetic aortic valve malpositioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Valve Migration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Valve Embolization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge Ectopic Valve Deployment (Procedural)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Prosthetic aortic valve malpositioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Valve Migration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Valve Embolization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Ectopic Valve Deployment (Procedural)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Prosthetic aortic valve malpositioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Valve Migration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Valve Embolization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Ectopic Valve Deployment (Procedural)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Prosthetic aortic valve malpositioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Valve Migration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Valve Embolization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Ectopic Valve Deployment (Procedural)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Prosthetic Aortic Valve Thrombosis</title>
        <description>Prosthetic aortic valve thrombosis</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Prosthetic Aortic Valve Thrombosis</title>
          <description>Prosthetic aortic valve thrombosis</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="3.9"/>
                    <measurement group_id="O4" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="6.9"/>
                    <measurement group_id="O4" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Prosthetic Aortic Valve Endocarditis</title>
        <description>Prosthetic aortic valve endocarditis</description>
        <time_frame>assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Lotus Valve System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O2">
            <title>CoreValve TAVR System - Randomized</title>
            <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O3">
            <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
          <group group_id="O4">
            <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
            <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Prosthetic Aortic Valve Endocarditis</title>
          <description>Prosthetic aortic valve endocarditis</description>
          <population>Intent to Treat</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="607"/>
                <count group_id="O2" value="305"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="3.9"/>
                    <measurement group_id="O4" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="4.0"/>
                    <measurement group_id="O4" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 Year</time_frame>
      <desc>For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up).&#xD;
For the SAE/AE tables, the at risk population (denominator) is the full ITT population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lotus Valve System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="E2">
          <title>CoreValve TAVR System - Randomized</title>
          <description>Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System&#xD;
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="E3">
          <title>Lotus Valve System - Single-arm Roll-in Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
        <group group_id="E4">
          <title>Lotus Valve System - Single-arm Continued Access Cohort</title>
          <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve System&#xD;
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="587"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="431" subjects_at_risk="607"/>
                <counts group_id="E2" subjects_affected="207" subjects_at_risk="305"/>
                <counts group_id="E3" subjects_affected="72" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="229" subjects_at_risk="295"/>
              </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="27" subjects_affected="27" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Heparin-induced thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anaemia macrocytic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anaemia of malignant disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="135" subjects_affected="135" subjects_at_risk="607"/>
                <counts group_id="E2" events="37" subjects_affected="37" subjects_at_risk="305"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="102"/>
                <counts group_id="E4" events="62" subjects_affected="62" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="75" subjects_affected="62" subjects_at_risk="607"/>
                <counts group_id="E2" events="54" subjects_affected="38" subjects_at_risk="305"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="102"/>
                <counts group_id="E4" events="24" subjects_affected="23" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="28" subjects_affected="28" subjects_at_risk="607"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="20" subjects_affected="17" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="305"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="607"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="305"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="607"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Conduction disorder</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="607"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Nodal rhythm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mitral perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intracardiac thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Electromechanical dissociation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Myocardial rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coronary artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sinus arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mitral valve calcification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mitral valve disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Trifascicular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ventricular asystole</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Peutz-Jeghers syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="305"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Peptic ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Umbilical hernia, obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oesophagitis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oesophageal spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intestinal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Inguinal hernia, obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastric antral vascular ectasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Colonic polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diverticulum oesophageal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Coeliac disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oesophageal rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site necrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Implant site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Implant site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hernia obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mechanical complication of implant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Alcoholic liver disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="607"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="16" subjects_affected="15" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="305"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="11" subjects_affected="9" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Osteomyelitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cellulitis staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Clostridial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Clostridium colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Viral labyrinthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cystitis klebsiella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Enterococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lung infection pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urinary tract infection pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Endocarditis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Infected sebaceous cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vascular procedure complication</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="607"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lead dislodgement</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Postoperative respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumothorax traumatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Drug toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Collapse of lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arterial injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac procedure complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pacemaker complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Frostbite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Operative haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pubic rami fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Post procedural stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Medical device complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac valve replacement complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Incisional hernia, obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Device lead damage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Traumatic brain injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Traumatic haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urinary bladder rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm ruptured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Echocardiogram abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase MB increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urine cytology abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Occult blood positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood lactic acid increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood culture positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anticoagulation drug level below therapeutic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Sinus rhythm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulse absent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QRS complex prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Clostridium difficile toxin test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>International normalised ratio abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pedal pulse decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Troponin T increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oral neoplasm benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oesophageal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Metastatic carcinoma of the bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mesothelioma malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hepatic cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Colorectal cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Adenoma benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tongue neoplasm malignant stage unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Prostatic adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bladder cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Benign breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Brain neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="607"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="305"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="607"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Chorea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Orthostatic intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhagic cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Brain stem syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Basal ganglia haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypoxic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Polydipsia psychogenic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="33" subjects_affected="32" subjects_at_risk="607"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="305"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Obstructive uropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pelvic haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Vaginal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="607"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="607"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="607"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="305"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Nasal septum perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Panniculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Dermatomyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Precancerous skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Activities of daily living impaired</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="607"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Labile blood pressure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arterial haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arterial thrombosis limb</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Subclavian artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Iliac artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Iliac artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Haemodynamic instability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Femoral arterial stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Extravasation blood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Diabetic macroangiopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Arterial rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="458" subjects_at_risk="607"/>
                <counts group_id="E2" subjects_affected="210" subjects_at_risk="305"/>
                <counts group_id="E3" subjects_affected="83" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="228" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="149" subjects_affected="146" subjects_at_risk="607"/>
                <counts group_id="E2" events="43" subjects_affected="42" subjects_at_risk="305"/>
                <counts group_id="E3" events="26" subjects_affected="26" subjects_at_risk="102"/>
                <counts group_id="E4" events="69" subjects_affected="67" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="88" subjects_affected="86" subjects_at_risk="607"/>
                <counts group_id="E2" events="56" subjects_affected="50" subjects_at_risk="305"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="102"/>
                <counts group_id="E4" events="51" subjects_affected="49" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="38" subjects_affected="37" subjects_at_risk="607"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="17" subjects_affected="17" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="229" subjects_affected="227" subjects_at_risk="607"/>
                <counts group_id="E2" events="87" subjects_affected="83" subjects_at_risk="305"/>
                <counts group_id="E3" events="40" subjects_affected="40" subjects_at_risk="102"/>
                <counts group_id="E4" events="103" subjects_affected="102" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="61" subjects_affected="58" subjects_at_risk="607"/>
                <counts group_id="E2" events="30" subjects_affected="29" subjects_at_risk="305"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="102"/>
                <counts group_id="E4" events="33" subjects_affected="33" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="53" subjects_affected="46" subjects_at_risk="607"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="305"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="44" subjects_affected="44" subjects_at_risk="607"/>
                <counts group_id="E2" events="24" subjects_affected="24" subjects_at_risk="305"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="35" subjects_affected="34" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Conduction disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="16" subjects_affected="16" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" events="38" subjects_affected="38" subjects_at_risk="607"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="30" subjects_affected="29" subjects_at_risk="607"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="24" subjects_affected="22" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="607"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="66" subjects_affected="62" subjects_at_risk="607"/>
                <counts group_id="E2" events="37" subjects_affected="34" subjects_at_risk="305"/>
                <counts group_id="E3" events="16" subjects_affected="15" subjects_at_risk="102"/>
                <counts group_id="E4" events="32" subjects_affected="28" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="31" subjects_affected="30" subjects_at_risk="607"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="305"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="102"/>
                <counts group_id="E4" events="21" subjects_affected="20" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Echocardiogram abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="18" subjects_affected="18" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="35" subjects_at_risk="607"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="31" subjects_affected="29" subjects_at_risk="607"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="607"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="23" subjects_affected="21" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="28" subjects_affected="26" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="64" subjects_affected="55" subjects_at_risk="607"/>
                <counts group_id="E2" events="42" subjects_affected="32" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="33" subjects_affected="32" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="41" subjects_affected="41" subjects_at_risk="607"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="305"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E4" events="19" subjects_affected="19" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="607"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="16" subjects_affected="15" subjects_at_risk="295"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="65" subjects_affected="61" subjects_at_risk="607"/>
                <counts group_id="E2" events="37" subjects_affected="37" subjects_at_risk="305"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" events="29" subjects_affected="29" subjects_at_risk="295"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="57" subjects_affected="56" subjects_at_risk="607"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="305"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="102"/>
                <counts group_id="E4" events="39" subjects_affected="37" subjects_at_risk="295"/>
              </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>A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Amy Maurer</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>508-683-6647</phone>
      <email>amy.maurer@bsci.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/NCT02202434
org study id: S2282
nct id: NCT02202434
lead sponsor: 
has dmc: Yes
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve
      System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in
      symptomatic subjects with calcific, severe native aortic stenosis who are considered at
      extreme or high risk for surgical valve replacement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Events Included in the Primary Safety Endpoint
time frame: 30 days following procedure
description: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
measure: Percentage of Participants With Events Included in the Primary Effectiveness Endpoint
time frame: 1 year following procedure
description: Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).
measure: Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation
time frame: 1 year following procedure
description: Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).
measure: Percentage of Participants With Successful Deployment of the Study Valve
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: Successful deployment of the study valve
measure: Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: Successful retrieval of the study valve if retrieval is attempted
measure: Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: Successful repositioning of the study valve if repositioning is attempted
measure: Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
measure: Percentage of Participants With Clinical Procedural Success
time frame: 30 days post procedure
description: Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding
measure: Percentage of Participants With Procedural Success
time frame: 30 days post procedure
description: Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for body surface area (BSA) <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events
measure: Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity
measure: Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Assessed by an independent core laboratory - mean and peak aortic gradients
measure: Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Assessed by an independent core laboratory - peak aortic velocity
measure: Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.
The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
measure: Health Status as Evaluated by Quality of Life Questionnaires
time frame: Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported
description: SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year
SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
measure: Percentage of Participants With Mortality
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: All-cause, Cardiovascular, and Non-cardiovascular
measure: Percentage of Participants With Stroke
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Disabling Stroke and Non-disabling Stroke
measure: Percentage of Participants With Myocardial Infarction (MI)
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
measure: Percentage of Participants With Bleeding
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Life-threatening (or disabling) and major (defined below)
Life-threatening or Disabling Bleeding
Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)
Major Bleeding (BARC type 3a)
Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding
measure: Percentage of Participants With Acute Kidney Injury
time frame: ≤7 days post index procedure
description: Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
Change in serum creatinine (up to 7 days) compared to baseline:
Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)
Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)
Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)
-OR-
Based on urine output (up to 7 days):
Stage 1: <0.5 ml/kg per hour for >6 but <12 hours
Stage 2: <0.5 ml/kg per hour for >12 but <24 hours
Stage 3: <0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours
Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
measure: Percentage of Participants With Major Vascular Complication
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Major vascular complication - including access site related and non access site related
measure: Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
measure: Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)
measure: Percentage of Participants With New Permanent Pacemaker Implantation
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: New permanent pacemaker implantation resulting from new or worsened conduction disturbances
measure: Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: New onset of atrial fibrillation or atrial flutter
measure: Percentage of Participants With Coronary Obstruction
time frame: ≤72 hours post index procedure
description: Coronary obstruction
measure: Percentage of Participants With Ventricular Septal Perforation
time frame: ≤72 hours post index procedure
description: Ventricular septal perforation
measure: Percentage of Participants With Mitral Apparatus Damage
time frame: ≤72 hours post index procedure
description: Mitral apparatus damage
measure: Percentage of Participants With Cardiac Tamponade
time frame: ≤72 hours post index procedure
description: Cardiac tamponade
measure: Percentage of Participants With Prosthetic Aortic Valve Malpositioning
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
measure: Percentage of Participants With Prosthetic Aortic Valve Thrombosis
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Prosthetic aortic valve thrombosis
measure: Percentage of Participants With Prosthetic Aortic Valve Endocarditis
time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
description: Prosthetic aortic valve endocarditis
arm group label: Lotus Valve System - Randomized
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
arm group label: CoreValve TAVR System - Randomized
arm group type: Active Comparator
description: Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
arm group label: Lotus Valve Sytem - Single-arm 21mm Cohort
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System
arm group label: Lotus Valve System - Single-arm Continued Access Cohort
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
arm group label: Lotus Valve System - Single-arm Roll-in Cohort
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
arm group label: LOTUS Edge Valve System - Single-arm Edge Nested Registry
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with 23mm, 25mm and 27mm LOTUS Edge Valve System.
intervention type: Device
intervention name: Lotus Valve System
description: Procedure: Transcatheter aortic valve replacement (TAVR)
arm group label: Lotus Valve System - Randomized
arm group label: Lotus Valve System - Single-arm Continued Access Cohort
arm group label: Lotus Valve System - Single-arm Roll-in Cohort
arm group label: Lotus Valve Sytem - Single-arm 21mm Cohort
intervention type: Device
intervention name: CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
description: Procedure: Transcatheter aortic valve replacement (TAVR)
arm group label: CoreValve TAVR System - Randomized
intervention type: Device
intervention name: LOTUS Edge Valve System
description: Procedure: Transcatheter aortic valve replacement (TAVR)
arm group label: LOTUS Edge Valve System - Single-arm Edge Nested Registry
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Rizik, MD
role: Principal Investigator
affiliation: Scottsdale Healthcare - Shea
last name: Michael J Reardon, MD
role: Principal Investigator
affiliation: The Methodist Hospital Research Institute
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country: Australia
country: Canada
country: France
country: Germany
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
provided document: 
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