<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/NCT03041467</url>
  </required_header>
  <id_info>
    <org_study_id>APV-IN.PACT AV Access</org_study_id>
    <nct_id>NCT03041467</nct_id>
  </id_info>
  <brief_title>IN.PACT™ AV Access IDE Study</brief_title>
  <official_title>Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Endovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Endovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB)&#xD;
      compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting&#xD;
      with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis&#xD;
      fistulae (AVF) in the upper extremity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial&#xD;
      evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous&#xD;
      transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or&#xD;
      non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in&#xD;
      the upper extremity. The trial will be conducted in up to 30 sites in the United States,&#xD;
      Japan, and New Zealand.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Actual">May 5, 2023</completion_date>
  <primary_completion_date type="Actual">December 6, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target Lesion Primary Patency Rate Through 6 Months</measure>
    <time_frame>6 Months Post-Procedure</time_frame>
    <description>Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint - Serious Adverse Event Rate</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Serious Adverse Event (SAE) rate involving the AV access circuit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Access Circuit Primary Patency</measure>
    <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
    <description>Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Primary Patency</measure>
    <time_frame>3, 9, 12, 18, and 24 Months</time_frame>
    <description>Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Target Lesion Revascularizations</measure>
    <time_frame>3, 6, 9,12, 18, and 24 Months</time_frame>
    <description>The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Interventions Required to Maintain Target Lesion Patency</measure>
    <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
    <description>The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Interventions Required to Maintain Access Circuit Patency</measure>
    <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
    <description>The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Access Circuit Thromboses</measure>
    <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
    <description>The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Success</measure>
    <time_frame>Time of Procedure</time_frame>
    <description>Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Success</measure>
    <time_frame>Time of Procedure</time_frame>
    <description>Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.</time_frame>
    <description>Resumption of successful dialysis for at least one session after index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Device Related Adverse Events</measure>
    <time_frame>30 days, 3, 6, 9, 12, 18, and 24 Months.</time_frame>
    <description>Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Related Adverse Event Rate</measure>
    <time_frame>30 Days, 3, 6, 9, 12, 18, and 24 Months</time_frame>
    <description>Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularizations (TLR)</measure>
    <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
    <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically-Driven Target Lesion Revascularizations (CD-TLR)</measure>
    <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
    <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-interventions in the Access Circuit</measure>
    <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
    <description>Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of Target AVF</measure>
    <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
    <description>Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Event Rate</measure>
    <time_frame>6, 12, 24, and 36 Months</time_frame>
    <description>Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Freedom From All-Cause Mortality Post Vital Status Update</measure>
    <time_frame>6, 12, 24, 36, and 48 Months</time_frame>
    <description>Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, and 48 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Arteriovenous Fistula Stenosis</condition>
  <condition>Arteriovenous Fistula Occlusion</condition>
  <condition>Arteriovenous Fistula</condition>
  <condition>Fistula</condition>
  <arm_group>
    <arm_group_label>IN.PACT AV DCB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the &quot;IN.PACT AV DCB.&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Balloon Angioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PTA will be performed using a commercially available uncoated PTA balloon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IN.PACT AV DCB</intervention_name>
    <description>IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
    <arm_group_label>IN.PACT AV DCB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Balloon Angioplasty</intervention_name>
    <description>Standard PTA Balloon</description>
    <arm_group_label>Standard Balloon Angioplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥21 years of age.&#xD;
&#xD;
          2. Patient has a life expectancy of ≥ 12 months&#xD;
&#xD;
          3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure&#xD;
&#xD;
          4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions&#xD;
             during a four week period&#xD;
&#xD;
          5. Patient has a de novo and/or non-stented restenotic lesion located between the&#xD;
             arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If&#xD;
             the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm&#xD;
             upstream on the arterial side. If the lesion is located in the cephalic arch, the&#xD;
             treatment may be delivered up to 2 cm into the subclavian vein&#xD;
&#xD;
          6. Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual&#xD;
             estimate) Note: Tandem lesions may be enrolled provided they meet all of the following&#xD;
             criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including&#xD;
             30 mm gap, ≤ 100 mm, and able to be treated as a single lesion&#xD;
&#xD;
          7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).&#xD;
&#xD;
          8. Patient underwent successful crossing of the target lesion with the guide wire and&#xD;
             pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of ≤ 30%&#xD;
             and absence of a flow limiting dissection (Grade ≥ C) or perforation&#xD;
&#xD;
          9. Patient provides written consent prior to enrollment in the study&#xD;
&#xD;
         10. Patient is willing to comply with all follow-up evaluations at specified times&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men&#xD;
             intending to father children&#xD;
&#xD;
          2. Patient is receiving immunosuppressive therapy&#xD;
&#xD;
          3. Patient is anticipating a kidney transplant within 6 months of enrollment into the&#xD;
             study&#xD;
&#xD;
          4. Patient has undergone prior intervention of access site within 30 days of index&#xD;
             procedure&#xD;
&#xD;
          5. Patient with anticipated conversion to peritoneal dialysis&#xD;
&#xD;
          6. Patient has an infected AV access or systemic infection&#xD;
&#xD;
          7. Patient has planned surgical revision of access site&#xD;
&#xD;
          8. Patient with secondary non-target lesion requiring treatment within 30-days post index&#xD;
             procedure&#xD;
&#xD;
          9. Patient with hemodynamically significant central venous stenoses that cannot be&#xD;
             successfully treated prior to treatment of the target lesion&#xD;
&#xD;
         10. Patient with target AVF or access circuit which previously had or currently has a&#xD;
             thrombosis&#xD;
&#xD;
         11. Patients judged to have a lesion that prevents complete inflation of an angioplasty&#xD;
             balloon or proper placement of the delivery system&#xD;
&#xD;
         12. Patient with target lesion located central to the axillosubclavian junction&#xD;
&#xD;
         13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm&#xD;
             upstream from the anastomosis in the AV access&#xD;
&#xD;
         14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion&#xD;
             site&#xD;
&#xD;
         15. Patient has presence of a stent located in the target AV access circuit&#xD;
&#xD;
         16. Patients with known allergies or sensitivities to paclitaxel&#xD;
&#xD;
         17. Patient with known contraindication, including allergic reaction, or sensitivity to&#xD;
             contrast material that cannot be adequately pre-treated&#xD;
&#xD;
         18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy&#xD;
&#xD;
         19. Patient with clinically significant Steal Syndrome requiring treatment&#xD;
&#xD;
         20. Patient is enrolled in another investigational drug, device, or biological study and&#xD;
             has not completed the primary endpoint, or was previously enrolled in this study&#xD;
&#xD;
         21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause&#xD;
             him/her to be non-compliant with the protocol of confound data interpretation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Lookstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Mount Sinai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Holden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auckland City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hiroaki Haruguchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haruguchi Vascular Access Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham (UAB) Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKI Vascular Center</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Nephrology Medical Group</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Vascular and Interventional</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Clinic Vein and Vascular Center</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's Daughters Medical Center</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</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>Holy Name Medical Center</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Nephrology PA</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysis Access Institute</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford University of South Dakota Medical Center</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Surgical Associates</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Nephrology Associates</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Vascular Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Vascular Center</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Institute of Virginia</name>
      <address>
        <city>Woodbridge</city>
        <state>Virginia</state>
        <zip>22193</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kishiwada Tokushukai Hospital</name>
      <address>
        <city>Kishiwada</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center Saitama Medical University</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka General Hospital</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital and Coast District Health Board</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>December 6, 2019</results_first_submitted>
  <results_first_submitted_qc>February 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 27, 2020</results_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</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>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 20, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03041467/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 7, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03041467/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>330 subjects from 21 US sites and 8 OUS sites contributed to the global cohort. 204 of subjects came from U.S. sites, 112 of subjects came from Japan sites, and 14 of subjects came from New Zealand sites. There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 20% of the total study subjects.</recruitment_details>
      <pre_assignment_details>A total of 488 patients were consented to be reviewed for enrollment. 158 patients were not enrolled in the study. 170 subjects were randomized to IN.PACT AV Drug Coated Balloon treatment and 160 subjects were randomized to the Standard PTA Treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>IN.PACT AV DCB</title>
          <description>PTA will be performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
        </group>
        <group group_id="P2">
          <title>Standard Balloon Angioplasty</title>
          <description>PTA will be performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="170"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>30 Days</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Months</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Months</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>9 Months</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 Months</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>18 Months</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>24 Months</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>36 Months</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>48 Months</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Declined consent for study extension</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Exit reason other than withdrawal, death, or lost to follow up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>48 Month visit not completed</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IN.PACT AV DCB</title>
          <description>PTA will be performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
        </group>
        <group group_id="B2">
          <title>Standard Balloon Angioplasty</title>
          <description>PTA will be performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="170"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="330"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.8" spread="13.1"/>
                    <measurement group_id="B2" value="65.5" spread="13.4"/>
                    <measurement group_id="B3" value="65.6" spread="13.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </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>New Zealand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="170"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>3 subjects in each treatment group did not provide data regarding ethnicity.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="167"/>
                    <count group_id="B2" value="157"/>
                    <count group_id="B3" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Target Lesion Primary Patency Rate Through 6 Months</title>
        <description>Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.</description>
        <time_frame>6 Months Post-Procedure</time_frame>
        <population>Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA will be performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA will be performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Primary Patency Rate Through 6 Months</title>
          <description>Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.</description>
          <population>Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="88"/>
                  </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;0.001</p_value>
            <method>One-sided Z-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Safety Endpoint - Serious Adverse Event Rate</title>
        <description>Serious Adverse Event (SAE) rate involving the AV access circuit</description>
        <time_frame>30 days post procedure</time_frame>
        <population>All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA will be performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA will be performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Safety Endpoint - Serious Adverse Event Rate</title>
          <description>Serious Adverse Event (SAE) rate involving the AV access circuit</description>
          <population>All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </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>Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <method>Farrington-Manning Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Access Circuit Primary Patency</title>
        <description>Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
        <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
        <population>There is no planned hypothesis test other than at 6 months time point.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Access Circuit Primary Patency</title>
          <description>Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
          <population>There is no planned hypothesis test other than at 6 months time point.</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="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4"/>
                    <measurement group_id="O2" value="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5"/>
                    <measurement group_id="O2" value="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8"/>
                    <measurement group_id="O2" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1"/>
                    <measurement group_id="O2" value="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6"/>
                    <measurement group_id="O2" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="25.4"/>
                  </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>
            <groups_desc>Kaplan-Meier method was used to estimate access circuit primary patency.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.</p_value_desc>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Primary Patency</title>
        <description>Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
        <time_frame>3, 9, 12, 18, and 24 Months</time_frame>
        <population>There is no planned hypothesis test other than at 6 months time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Primary Patency</title>
          <description>Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
          <population>There is no planned hypothesis test other than at 6 months time-point.</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="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9"/>
                    <measurement group_id="O2" value="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6"/>
                    <measurement group_id="O2" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3"/>
                    <measurement group_id="O2" value="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4"/>
                    <measurement group_id="O2" value="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2"/>
                    <measurement group_id="O2" value="36.2"/>
                  </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>
            <groups_desc>Kaplan-Meier method was used to estimate target lesion primary patency.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.</p_value_desc>
            <method>Log Rank</method>
            <other_analysis_desc>Survival analysis was performed using Kaplan-Meier method.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Target Lesion Revascularizations</title>
        <description>The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
        <time_frame>3, 6, 9,12, 18, and 24 Months</time_frame>
        <population>Participants are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Target Lesion Revascularizations</title>
          <description>The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.</description>
          <population>Participants are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="101"/>
                  </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;0.001</p_value>
            <p_value_desc>There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Interventions Required to Maintain Target Lesion Patency</title>
        <description>The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.</description>
        <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Interventions Required to Maintain Target Lesion Patency</title>
          <description>The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.</description>
          <units>Total number of interventions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Interventions Required to Maintain Access Circuit Patency</title>
        <description>The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.</description>
        <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Interventions Required to Maintain Access Circuit Patency</title>
          <description>The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.</description>
          <units>Total number of interventons</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Access Circuit Thromboses</title>
        <description>The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
        <time_frame>3, 6, 9, 12, 18, and 24 Months</time_frame>
        <population>Participant withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Access Circuit Thromboses</title>
          <description>The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
          <population>Participant withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Access Circuit Thromboses Within 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access Circuit Thromboses Within 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access Circuit Thromboses Within 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access Circuit Thromboses Within 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access Circuit Thromboses Within 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access Circuit Thromboses Within 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Success</title>
        <description>Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.</description>
        <time_frame>Time of Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Device Success</title>
          <description>Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.</description>
          <units>Devices successfully used</units>
          <param>Number</param>
          <units_analyzed>Devices used</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Devices used</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212"/>
                    <measurement group_id="O2" value="161"/>
                  </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>&gt;0.999</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Success</title>
        <description>Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).</description>
        <time_frame>Time of Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Success</title>
          <description>Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="122"/>
                  </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>0.482</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Success</title>
        <description>Resumption of successful dialysis for at least one session after index procedure.</description>
        <time_frame>From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Success</title>
          <description>Resumption of successful dialysis for at least one session after index procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="154"/>
                  </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>&gt;0.999</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Device Related Adverse Events</title>
        <description>Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
        <time_frame>30 days, 3, 6, 9, 12, 18, and 24 Months.</time_frame>
        <population>Number of Participants with One or More Device-Related Adverse Events</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Device Related Adverse Events</title>
          <description>Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
          <population>Number of Participants with One or More Device-Related Adverse Events</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with device related AEs within 30 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with device related AEs within 24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Related Adverse Event Rate</title>
        <description>Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
        <time_frame>30 Days, 3, 6, 9, 12, 18, and 24 Months</time_frame>
        <population>Number of Participants with One or More Procedure-Related Adverse Events</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Related Adverse Event Rate</title>
          <description>Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.</description>
          <population>Number of Participants with One or More Procedure-Related Adverse Events</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with Procedure-Related AEs within 30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Procedure-Related AEs within 24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularizations (TLR)</title>
        <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
        <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
        <population>There is no planned hypothesis test.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Revascularizations (TLR)</title>
          <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
          <population>There is no planned hypothesis test.</population>
          <units>% of Cumulative Incidence Rate</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                    <measurement group_id="O2" value="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                    <measurement group_id="O2" value="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7"/>
                    <measurement group_id="O2" value="59.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                    <measurement group_id="O2" value="66.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.6"/>
                    <measurement group_id="O2" value="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                    <measurement group_id="O2" value="79.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically-Driven Target Lesion Revascularizations (CD-TLR)</title>
        <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure</description>
        <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
        <population>There is no planned hypothesis test for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically-Driven Target Lesion Revascularizations (CD-TLR)</title>
          <description>Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure</description>
          <population>There is no planned hypothesis test for this endpoint.</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="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3"/>
                    <measurement group_id="O2" value="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4"/>
                    <measurement group_id="O2" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.7"/>
                    <measurement group_id="O2" value="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="60.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0"/>
                    <measurement group_id="O2" value="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9"/>
                    <measurement group_id="O2" value="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Re-interventions in the Access Circuit</title>
        <description>Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
        <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
        <population>There is no planned hypothesis test for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Re-interventions in the Access Circuit</title>
          <description>Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.</description>
          <population>There is no planned hypothesis test for this endpoint.</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="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4"/>
                    <measurement group_id="O2" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2"/>
                    <measurement group_id="O2" value="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7"/>
                    <measurement group_id="O2" value="65.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                    <measurement group_id="O2" value="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.8"/>
                    <measurement group_id="O2" value="74.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9"/>
                    <measurement group_id="O2" value="83.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abandonment of Target AVF</title>
        <description>Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.</description>
        <time_frame>6, 9, 12, 18, 24, and 36 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Abandonment of Target AVF</title>
          <description>Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Event Rate</title>
        <description>Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.</description>
        <time_frame>6, 12, 24, and 36 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Event Rate</title>
          <description>Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with SAEs within 180 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with SAEs within 360 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with SAEs within 720 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with SAEs within 1080 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Freedom From All-Cause Mortality Post Vital Status Update</title>
        <description>Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, and 48 months.</description>
        <time_frame>6, 12, 24, 36, and 48 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IN.PACT AV DCB</title>
            <description>PTA was performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
          </group>
          <group group_id="O2">
            <title>Standard Balloon Angioplasty</title>
            <description>PTA was performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Freedom From All-Cause Mortality Post Vital Status Update</title>
          <description>Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, and 48 months.</description>
          <units>% of Survival</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Within 180 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.4"/>
                    <measurement group_id="O2" value="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 360 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.1"/>
                    <measurement group_id="O2" value="89.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 720 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.2"/>
                    <measurement group_id="O2" value="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1080 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4"/>
                    <measurement group_id="O2" value="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1440 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4"/>
                    <measurement group_id="O2" value="58.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.</time_frame>
      <desc>All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table.</desc>
      <group_list>
        <group group_id="E1">
          <title>IN.PACT AV DCB</title>
          <description>PTA will be performed using the IN.PACT AV Drug Coated Balloon.&#xD;
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon</description>
        </group>
        <group group_id="E2">
          <title>Standard Balloon Angioplasty</title>
          <description>PTA will be performed using a commercially available uncoated PTA balloon.&#xD;
Standard Balloon Angioplasty: Standard PTA Balloon</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</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="53" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="148" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="143" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Anaemia Of Chronic Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Blood Loss Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Nephrogenic Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Acute Left Ventricular Failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Aortic Valve Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis Coronary Artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="170"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardio-Respiratory Arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Chronic Left Ventricular Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coronary Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diastolic Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ischaemic Cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulseless Electrical Activity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Acetylcholinesterase Deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness Neurosensory</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism Secondary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vitreous Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Colitis Ischaemic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diabetic Gastroparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diverticulum Intestinal Haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Faeces Discoloured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastric Polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Intra-Abdominal Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ischaemic Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Large Intestinal Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lower Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Mesenteric Arterial Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Mesenteric Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Oesophageal Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Portal Hypertensive Gastropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Upper Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Complication Associated With Device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Physical Deconditioning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Stent-Graft Endoleak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Strangulated Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Stent Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Stent Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hepatic Cirrhosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney Transplant Rejection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Acinetobacter Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Graft Site Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arthritis Bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bacterial Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coronavirus Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Covid-19 Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Enterococcal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Escherichia Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Groin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Infected Dermal Cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Infected Skin Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Klebsiella Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Necrotising Fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="170"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumonia Staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Portal Pyaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulmonary Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Respiratory Syncytial Virus Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Staphylococcal Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Staphylococcal Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Wound Infection Staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Wound Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Aneurysm</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Occlusion</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E2" events="37" subjects_affected="19" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Complication</sub_title>
                <counts group_id="E1" events="355" subjects_affected="85" subjects_at_risk="170"/>
                <counts group_id="E2" events="407" subjects_affected="95" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Thrombosis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Graft Site Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Burns Second Degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Complications Of Transplanted Kidney</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Coronary Artery Restenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemodialysis Complication</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Inadequate Haemodialysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Incarcerated Incisional Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Multiple Fractures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Rectal Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Shunt Malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Skull Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Toxicity To Various Agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ulna Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Access Malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Access Site Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Graft Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Vascular Graft Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Anticoagulation Drug Level Below Therapeutic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Blood Pressure Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Brain Natriuretic Peptide Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Occult Blood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Failure To Thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="170"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lactic Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arthritis Reactive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis Pyrophosphate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Foot Deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lumbar Spinal Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Rheumatoid Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Spinal Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Angiosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Breast Angiosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hepatic Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lung Adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Metastases To Peritoneum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Myelodysplastic Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Parathyroid Tumour Benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pituitary Tumour Benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Prostate Cancer Metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Renal Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Brain Stem Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Carpal Tunnel Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cervical Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cubital Tunnel Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Cerebral Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypertensive Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Lacunar Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Myelopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Narcolepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Neuropathy Peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Spondylitic Myelopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Thrombotic Cerebral Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Toxic Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Delirium Tremens</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>End Stage Renal Disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Renal Cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Renal Mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </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="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="15" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Respiratory Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Generalised Exanthematous Pustulosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dermal Cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dermatitis Exfoliative Generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diabetic Foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Erythema Multiforme</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Ischaemic Skin Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Skin Mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Loss Of Personal Independence In Daily Activities</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Refusal Of Treatment By Patient</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula Operation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Cardiac Pacemaker Replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dialysis Device Insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Leg Amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Revascularisation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Renal Transplant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Aortic Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Brachiocephalic Vein Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dry Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Extremity Necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypertensive Emergency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypertensive Urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Peripheral Vascular Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Shock Haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Steal Syndrome</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Subclavian Artery Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Subclavian Vein Occlusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Subclavian Vein Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Subclavian Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Superior Vena Cava Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Venous Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Venous Thrombosis Limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="31" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula Site Complication</sub_title>
                <counts group_id="E1" events="76" subjects_affected="31" subjects_at_risk="170"/>
                <counts group_id="E2" events="124" subjects_affected="32" subjects_at_risk="160"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Phally Roffe, Clinical Study Manager</name_or_title>
      <organization>Medtronic</organization>
      <phone>763.526.0350</phone>
      <email>phally.s.roffe@medtronic.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/NCT03041467
org study id: APV-IN.PACT AV Access
nct id: NCT03041467
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB)
      compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting
      with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis
      fistulae (AVF) in the upper extremity.
This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial
      evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous
      transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or
      non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in
      the upper extremity. The trial will be conducted in up to 30 sites in the United States,
      Japan, and New Zealand.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Target Lesion Primary Patency Rate Through 6 Months
time frame: 6 Months Post-Procedure
description: Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
measure: Primary Safety Endpoint - Serious Adverse Event Rate
time frame: 30 days post procedure
description: Serious Adverse Event (SAE) rate involving the AV access circuit
measure: Access Circuit Primary Patency
time frame: 3, 6, 9, 12, 18, and 24 Months
description: Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
measure: Target Lesion Primary Patency
time frame: 3, 9, 12, 18, and 24 Months
description: Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.
measure: Cumulative Target Lesion Revascularizations
time frame: 3, 6, 9,12, 18, and 24 Months
description: The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
measure: Total Number of Interventions Required to Maintain Target Lesion Patency
time frame: 3, 6, 9, 12, 18, and 24 Months
description: The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.
measure: Total Number of Interventions Required to Maintain Access Circuit Patency
time frame: 3, 6, 9, 12, 18, and 24 Months
description: The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.
measure: Cumulative Access Circuit Thromboses
time frame: 3, 6, 9, 12, 18, and 24 Months
description: The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Device Success
time frame: Time of Procedure
description: Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
measure: Procedure Success
time frame: Time of Procedure
description: Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
measure: Clinical Success
time frame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
description: Resumption of successful dialysis for at least one session after index procedure.
measure: Rate of Device Related Adverse Events
time frame: 30 days, 3, 6, 9, 12, 18, and 24 Months.
description: Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Procedure Related Adverse Event Rate
time frame: 30 Days, 3, 6, 9, 12, 18, and 24 Months
description: Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Target Lesion Revascularizations (TLR)
time frame: 6, 9, 12, 18, 24, and 36 Months
description: Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
measure: Clinically-Driven Target Lesion Revascularizations (CD-TLR)
time frame: 6, 9, 12, 18, 24, and 36 Months
description: Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure
measure: Re-interventions in the Access Circuit
time frame: 6, 9, 12, 18, 24, and 36 Months
description: Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
measure: Abandonment of Target AVF
time frame: 6, 9, 12, 18, 24, and 36 Months
description: Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.
measure: Serious Adverse Event Rate
time frame: 6, 12, 24, and 36 Months
description: Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.
measure: Rate of Freedom From All-Cause Mortality Post Vital Status Update
time frame: 6, 12, 24, 36, and 48 Months
description: Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, and 48 months.
arm group label: IN.PACT AV DCB
arm group type: Experimental
description: PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."
arm group label: Standard Balloon Angioplasty
arm group type: Active Comparator
description: PTA will be performed using a commercially available uncoated PTA balloon.
intervention type: Device
intervention name: IN.PACT AV DCB
description: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
arm group label: IN.PACT AV DCB
intervention type: Device
intervention name: Standard Balloon Angioplasty
description: Standard PTA Balloon
arm group label: Standard Balloon Angioplasty
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Lookstein, MD
role: Principal Investigator
affiliation: The Mount Sinai Hospital
last name: Andrew Holden, MD
role: Principal Investigator
affiliation: Auckland City Hospital
last name: Hiroaki Haruguchi, MD
role: Principal Investigator
affiliation: Haruguchi Vascular Access Clinic
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country: Japan
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No
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